0 risk factors: 0.4%; 1 risk factor 0.9%; 2 risk factors 6.6%; 3 or more 11%
Coronary artery disease.
Coronary artery disease (CAD) increases the risk of perioperative morbidity and mortality, especially in the context of a recent myocardial infarction (MI) or coronary revascularization (CABG or PCI). For patients who have had a recent MI (within six months), the risk of both MACE and mortality is highest in the first 30 days following the MI (32.8% and 14.2%, respectively). 15 These patients are also at an eight-fold increased risk of stroke. 16 It is therefore recommended that elective, non-cardiac surgery be delayed for at least 60 days following an MI without coronary intervention.
Many patients with coronary artery disease who have had percutaneous coronary intervention (PCI) with balloon angioplasty or coronary artery stents present for non-cardiac surgery. 17 Up to 26% of patients with either a bare metal stent (BMS) or drug-eluting stent (DES) will require surgery within five years of undergoing PCI. 18 Drug eluting stents offer more protection than BMS against re-stenosis from smooth muscle proliferation but are slower to re-endothelialize and thus require a longer period of dual anti-platelet therapy (DAPT) to prevent life threatening stent thrombosis. It is known that premature discontinuation of DAPT increases the risk of stent thrombosis, especially in patients undergoing surgery, which induces a hypercoagulable state. The risk of MACE is highest (10.5%) in those patients with BMS who undergo surgery within 30 days after PCI, and lowest (2.8%) in those who wait at least 90 days. 19 Another study found that MACE was highest when major non-cardiac surgery was performed less than 45 days after implantation of any coronary stent. 20 Following placement of a DES, the risk of MACE is lowest in those who wait at least 365 days before non-cardiac surgery. In both cases, the risk of MACE is higher when surgery is performed on an emergent basis. For patients undergoing surgery prior to completion of DAPT, the theoretical risk of surgical bleeding while on DAPT must be balanced with the risk of stent thrombosis if dual antiplatelet therapy is held for surgery. Decisions about management of DAPT should be made in concert with the patient’s cardiologist. The updated ACC/AHA guidelines recommend delaying elective non-cardiac surgery for 14 days following balloon angioplasty, at least 30 days following BMS implantation, and 365 days following DES implantation, although in some cases a waiting period of 180 days after DES implantation may be appropriate.
For practitioners involved in the evaluation of patients with coronary artery disease preparing for surgery, a stepwise approach is available to assist in patient evaluation and estimation of risk. (See Figure 1 ). Patients who are planning surgery with low risk of MACE and those at elevated risk of MACE with at least moderate functional capacity (>4 METS as defined by the ability to climb a flight of stairs without stopping, walking uphill with ease, or gardening) can proceed to surgery without further evaluation. Patients with poor or unknown functional capacity may benefit from pharmacologic stress testing if it will influence their decision to have surgery or change perioperative management. Patients who elect to undergo stress testing may be candidates for coronary angiography or revascularization prior to surgery. Similar recommendations are available for managing patients with heart failure, arrhythmias, and heart valve disease. 10
Stepwise Approach to Perioperative Cardiac Assessment: Treatment Algorithm.
Reprinted with permission Circulation.
2014;130:2215–2245 ©2014 American Heart Association, Inc.
As part of any assessment of cardiovascular health, it is important to differentiate between active cardiac conditions and stable clinical risk factors. Patients with active cardiac conditions (acute coronary syndromes, decompensated heart failure, significant arrhythmias, or severe valvulopathy) are at high risk for perioperative MACE and should be evaluated and treated according to guideline-directed medical therapy. 21 For those with clinical risk factors (history of CVA, history of ischemic heart disease, history of congestive heart failure, diabetes, or kidney failure), the revised cardiac risk index or a similar risk calculator should be used along with procedural factors to estimate the risk perioperative MACE prior to surgery.
Additional tests and studies such as electrocardiograms (ECGs), chest x-rays, and blood tests are often ordered as a matter of routine—actions that are often based on medicolegal concerns or perceived expectations rather than on evidence based guidelines. 22 Twelve lead ECGs may be informative in patients with known cardiovascular disease, but are not indicated for asymptomatic patients undergoing low risk procedures. 10 As many as 45% of asymptomatic patients have abnormal ECG findings. 5 There is also no agreed upon minimum age requirement for ECG testing among asymptomatic patients. Similarly, chest x-rays were once included as part of any preoperative evaluation, but abnormal findings may be present in up to 60% of asymptomatic patients and can lead to costly and unnecessary postponement or cancellation of surgery, changes in medical management that otherwise would not have occurred, and excess radiation exposure. The same is true of laboratory tests such as hemoglobin and hematocrit measures, serum chemistries, and coagulation profiles. It is now recommended that these tests should only be ordered when clearly indicated (i.e., to answer a specific question and only if it will lead to a change in management).
Many patients with cardiovascular disease presenting for preoperative evaluation are on chronic antihypertensive therapy. The use of beta adrenergic antagonists (beta blockers) has been the subject of several studies in recent years. 23 , 24 It is now recommended that patients who are on chronic beta blocker therapy remain so throughout the perioperative period. For beta blocker naive patients, beta blockers may reduce perioperative cardiac risk, but are associated with adverse effects such as bradycardia, hypotension, and stroke. Therefore, initiating beta blocker therapy on the day of surgery is not recommended. Patients taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) on the day of surgery may experience transient hypotension, but are at no increased risk of adverse cardiac events, and continuing these medications in the perioperative period is reasonable. 10
One strategy to reduce length of stay and prevent postoperative complications is the concept of early patient engagement in the preoperative period or “prehabilitation” (enhancing functional capacity in preparation for a stressful event such as surgery). 25 This is especially relevant to elderly patients with chronic respiratory disease who are at increased risk for postoperative pulmonary complications, which they tolerate poorly. Ergina et al. reported that identifying patients with COPD who smoke and have poor functionality and instituting perioperative regimens that include smoking cessation, bronchodilators, chest physiotherapy, postural drainage, and deep breathing exercises reduced the incidence of postoperative pulmonary complications. 26 Other investigators have reported on the benefits of preoperative aerobic exercise training on postoperative recovery from colorectal surgery. 27 , 28 Others have shown that prehabilitation programs have a positive impact on length of stay and health-related quality of life measures. 29
Despite the long-known health risks of tobacco use, 19.2% of American adults report smoking every day or some days. 30 Tobacco-related diseases are the leading cause of preventable deaths worldwide, contributing to 443,000 deaths per year in the U.S. and nearly $200 billion annually in medical expenses and lost productivity. 31 One half of people who continue to smoke will die of a tobacco-related illness. Lung cancer is the most prevalent type of cancer in the world and the leading cause of cancer death in the United States, accounting for 27% of the expected 589,000 U.S. cancer deaths in 2015. The majority of lung cancer deaths are caused by smoking.
The benefits of smoking cessation prior to surgery are well known. Within hours of stopping, blood levels of carbon monoxide and nicotine decline, leading to improved blood flow and oxygen delivery to tissues. 32 , 33 After several weeks, some aspects of airway inflammation and hyperreactivity improve, including mucociliary clearance, symptoms of coughing and wheezing, and the decline of pulmonary function as measured by lung spirometry. Conversely, patients who continue to smoke in the perioperative period are at increased risk for infection and impaired wound healing, as well as perioperative pulmonary complications such as respiratory failure requiring unplanned ICU admission, pneumonia, and airway complications related to anesthesia. The precise amount of time required to fully realize the benefits of smoking cessation are unknown, with some requiring up to 6 months, and even brief periods of cessation are helpful, but longer is assumed to be better. 33 A recent review of the literature found that compared with current smokers, those who abstain from smoking for at least four weeks (and preferably for at least eight weeks) prior to surgery experience lower rates of respiratory complications and fewer instances of impaired wound healing. 34
Surgery presents a unique opportunity for health professionals to encourage smoking cessation. A teachable moment occurs when a patient is faced with the recent diagnosis of a serious illness or the prospect of surgery. 35 Quit rates are higher following major surgery, especially surgery related to conditions associated with smoking. Heightened awareness of risks and potential negative consequences may provide additional motivation to reduce or quit smoking and patients may be more receptive to anti-smoking discussions, especially when initiated by a physician or other health care professional. 32
For surgical patients (and non-surgical patients) who are willing to make a quit attempt and be smoke-free for surgery, and for the physicians who care for them, there are effective smoking cessation resources available in the form of tobacco dependence counseling and medication treatments. 36
The Brief Intervention is a practical tool that busy clinicians can use during a routine preoperative clinic visit. 37 It is effective in reducing smoking rates in surgical patients and is based on the “5 A” model for reducing tobacco use and dependence: Ask—“Do you smoke?” and “Do you want to quit?” Advise— Strongly urge all tobacco users to quit. Assess—Determine willingness to make a quit attempt. Assist—Provide counseling and medication. Arrange—Ensure follow-up contact. Although intensive behavioral counselling that involves problem solving training and social support is most effective, national telephone tobacco quitlines (1-800-QUIT-NOW) and web-based resources ( http://www.smokefree.gov ) are also useful. 38 Smoking cessation counseling is effective even for those not yet willing to make a quit attempt. 39
All patients attempting to quit smoking should be encouraged to use effective first line medications unless medically contraindicated (e.g., Bupropion SR, varenicline, and nicotine replacement therapy, which includes gum, lozenges, and patches). When used together, tobacco dependence counseling and medications are most effective in increasing quitting success and reducing withdrawal symptoms. 40
Evidence-based smoking cessation strategies are not only efficacious, but are also cost effective and consistent with the Healthy People 2020 objective of reducing the prevalence of cigarette smoking among U.S. adults to less than 12%. To this end, the 2010 Patient Protection and Affordable Care Act provides expanded coverage for evidence-based smoking cessation treatments.
The preoperative evaluation offers physicians and other health care professional a unique opportunity to help patients optimize their health prior to surgery. Updated, evidence-based guidelines can assist providers in selecting the most appropriate methods of patient evaluation while making the most efficient use of limited health care resources. This includes encouraging healthy behavioral modifications. It is important to bear in mind that the patient always has the final say in any decision to undergo surgery. Therefore, these guidelines are best used to aid shared decision-making, taking into consideration the patient’s perspective on the risks and benefits of surgery.
Frederick T. O’Donnell, MD, is in the University of Missouri-Columbia Health Care Department of Anesthesiology and Perioperative Medicine.
Contact: ude.iruossim.htlaeh@fllennodo
None reported.
Intended for healthcare professionals
A guide on how to structure a case presentation
-History of presenting problem
-Medical and surgical history
-Drugs, including allergies to drugs
-Family history
-Social history
-Review of systems
-Findings on examination, including vital signs and observations
-Differential diagnosis/impression
-Investigations
-Management
Presenting patient cases is a key part of everyday clinical practice. A well delivered presentation has the potential to facilitate patient care and improve efficiency on ward rounds, as well as a means of teaching and assessing clinical competence. 1
The purpose of a case presentation is to communicate your diagnostic reasoning to the listener, so that he or she has a clear picture of the patient’s condition and further management can be planned accordingly. 2 To give a high quality presentation you need to take a thorough history. Consultants make decisions about patient care based on information presented to them by junior members of the team, so the importance of accurately presenting your patient cannot be overemphasised.
As a medical student, you are likely to be asked to present in numerous settings. A formal case presentation may take place at a teaching session or even at a conference or scientific meeting. These presentations are usually thorough and have an accompanying PowerPoint presentation or poster. More often, case presentations take place on the wards or over the phone and tend to be brief, using only memory or short, handwritten notes as an aid.
Everyone has their own presenting style, and the context of the presentation will determine how much detail you need to put in. You should anticipate what information your senior colleagues will need to know about the patient’s history and the care he or she has received since admission, to enable them to make further management decisions. In this article, I use a fictitious case to …
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Case study: surgical oncology, renal retroperitoneal mass adherent to the inferior vena cava with blood conservation by cell saver and intraoperative normovolemic hemodilution (ianh).
A 68-year old woman who is one of Jehovah’s Witnesses presented with general malaise and some left upper quadrant pain and nausea. Her history was significant for a right nephrectomy for renal cell carcinoma 15 years ago. A CT scan revealed a heterogeneous mass located in the right-sided retroperitoneal space measuring 8 by 11 cm with compression of the inferior vena cava (IVC) and effacement of the gallbladder. In addition, she had a pacemaker implant 3 years prior, for the treatment of sick sinus syndrome.
Two surgeons, Dr. James Black from vascular surgery, and Dr. Mohamed Allaf from Urology as well as Dr. Steven Frank, the Medical Director of the Center for Bloodless Medicine and Surgery were consulted. Drs. Frank and Allaf saw her at the same time together, along with her family members, to map out an intraoperative plan. On reviewing the CT scans, the three physicians decided that a surgical resection would be high-risk, given the involvement of the vena cava, and that the risk of bleeding was significant. The risks and benefits of the procedure, as well as the available blood conservation techniques were discussed with the patient and her family. It was decided that by using autologous blood salvage (Cell Saver), along with a special leukoreduction filter, the risks would be minimized and the planned procedure could be accomplished. Intraoperative autologous normovolemic hemodilution (IANH) was also discussed as a blood conservation technique and the patient agreed this was acceptable to minimize risks.
The preoperative hemoglobin level was 14.7 g/dL, which was thought to be adequate for this surgical procedure. The anesthesia plan was developed by Dr. Frank, which included a thoracic epidural to minimize both postoperative pain and the requirement for narcotic pain medications. Large bore venous access was placed after induction of general anesthesia, using three 8.5 French introducers, 2 in the right and 1 in the left internal jugular veins. An intra-arterial catheter was also placed in the radial artery for continuous blood pressure monitoring. This degree of venous access would allow for veno-veno bypass from the iliac vein to the right atrium, if a vena cava cross clamp was necessary to remove the tumor. Prior to incision, 2 units of fresh whole blood were removed into CPDA anticoagulant bags, but remained in continuity with the patient’s circulation (via IV tubing) at all times. A volume expander (albumin) along with 2 liters of crystalloid solution were given for the hemodilution technique. Phenylephrine was given to maintain blood pressure during the IANH phlebotomy to allow the safe removal of autologous blood.
The surgery was performed through a right-sided thoraco-abdominal incision, and the diaphragm was taken down to provide access to the tumor. The tumor was identified and was adherent to the vena cava, but appeared to be resectable. A sidebiting cross clamp was applied to the cava, the tumor was removed, and the cava was repaired. There was no need for veno-veno bypass as the patient tolerated the partial cross clamp with hemodynamic stability. The blood loss was substantial (1,200 mLs) which for her body mass (50kg) was about 1/3 of her entire blood volume (calculated as 70 mL per kg or 3,500 mLs). The shed blood was processed through the Cell Saver and returned to the patient using the leukoreduction filter to minimize and chances of spreading tumor cells. The 2 units of autologous whole blood were given back to her near the end of the procedure. The closure included repair of the diaphragm and no chest tube was required.
On postoperative day #1 she was sitting up in a chair and on postoperative day #2 she was walking. A duplex ultrasound exam of the vena cava and iliac veins revealed good blood flow, and no narrowing or thrombosis. Pain scores and narcotic requirements were minimal due to the thoracic epidural. The pathology report came back as recurrent papillary renal cell carcinoma, with clean margins, indicating the tumor was completely resected. She was discharged to home on postoperative day #7 to be followed up by Oncology.
BMC Geriatrics volume 24 , Article number: 561 ( 2024 ) Cite this article
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No study has compared 30-day and 90-day adverse postoperative outcomes between old-age patients with and those without sarcopenia.
We categorize elderly patients receiving major surgery into two groups according to the presence or absence of preoperative sarcopenia that were matched at a 1:4 ratio through propensity score matching (PSM). We analyzed 30-day or 90-day adverse postoperative outcomes and mortality in patients with and without sarcopenia receiving major surgery.
Multivariate logistic regression analyses revealed that the patients with preoperative sarcopenia were at significantly higher risk of 30-day postoperative mortality (adjusted odds ratio [aOR]. = 1.25; 95% confidence interval [CI]. = 1.03–1.52) and 30-day major complications such as postoperative pneumonia (aOR = 1.15; 95% CI = 1.00-1.40), postoperative bleeding (aOR = 2.18; 95% CI = 1.04–4.57), septicemia (aOR = 1.31; 95% CI = 1.03–1.66), and overall complications (aOR = 1.13; 95% CI = 1.00-1.46). In addition, surgical patients with sarcopenia were at significantly higher risk of 90-day postoperative mortality (aOR = 1.50; 95% CI = 1.29–1.74) and 90-day major complications such as pneumonia (aOR = 1.27; 95% CI = 1.10–1.47), postoperative bleeding (aOR = 1.90; 95% CI = 1.04–3.48), septicemia (aOR = 1.52; 95% CI = 1.28–1.82), and overall complications (aOR = 1.24; 95% CI = 1.08–1.42).
Sarcopenia is an independent risk factor for 30-day and 90-day adverse postoperative outcomes such as pneumonia, postoperative bleeding, and septicemia and increases 30-day and 90-day postoperative mortality among patients receiving major surgery.
No study has compared 30-day and 90-day adverse postoperative outcomes between patients with and those without sarcopenia. We conducted a propensity score?matched (PSM) population-based cohort study to investigate the adverse postoperative outcomes and mortality in patients undergoing major elective surgery with preoperative sarcopenia versus those without preoperative sarcopenia. We demonstrated that sarcopenia is an independent risk factor for 30-day and 90-day adverse postoperative outcomes, such as postoperative pneumonia, bleeding, septicemia, and mortality after major surgery. Therefore, surgeons and anesthesiologists should attempt to correct preoperative sarcopenia, swallowing function, and respiratory muscle training before elective surgery to reduce postoperative complications that contribute to the decrease in surgical mortality.
Peer Review reports
Sarcopenia is defined as the progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes, such as physical disability, poor quality of life, and even death [ 1 ]. Lifestyle, physical inactivity, malnutrition, and chronic diseases (e.g., osteoporosis and metabolic diseases) are all risk factors for sarcopenia [ 2 , 3 , 4 ]. Currently, the pathogenesis of sarcopenia is unclear. However, sarcopenia may be related to genetics, nutritional deficiencies, neuromuscular function, hormones, autophagy, mitochondrial abnormalities, and gut flora [ 5 , 6 ]. Sarcopenia not only increases the fall rate, disability rate, hospitalization rate, surgical complication rate, and even mortality but also affects the occurrence, development, and prognosis of various diseases [ 7 ]. However, research on sarcopenia is currently in the exploratory stage, and the association of preoperative sarcopenia with surgery is unclear.
The mass and strength of skeletal muscles are affected by various factors, such as age, gender, underlying diseases, dietary habits, and exercise, and can reflect the overall functional status [ 8 ]. In general, the prognosis of surgical patients is closely related to the functional status [ 9 ]. Patients with sarcopenia, as a special group, often exhibit low physical function, and they may be at an increased risk of postsurgical complications [ 10 , 11 ]. Moreover, sarcopenia can lead to a decrease in skeletal muscle and the weakening of respiratory and swallowing muscles, thereby resulting in atelectasis, pneumonia, dysphagia, and malnutrition [ 12 ]. These aforementioned factors may increase postoperative complications and mortality, prolong hospital stay, affect quality of life, and increase health-care costs [ 13 ]. Therefore, surgeons and anesthesiologists should pay increased attention to patients with sarcopenia, as a potential high-risk group for adverse postoperative outcomes.
The influence of preoperative sarcopenia on the prognosis of major postoperative outcomes is unclear. The findings of previous studies on the association of sarcopenia with adverse postoperative outcomes and mortality are conflicting, and studies with an adequate sample size, clear definition of sarcopenia, and satisfactory results are scant [ 13 , 14 , 15 , 16 ]. Therefore, large-scale clinical research should be conducted on the prognosis of postoperative outcomes in patients with sarcopenia by utilizing a real-world database. Therefore, we conducted a comparative study through PSM to estimate the effects of preoperative sarcopenia on the outcomes of elective surgery.
We used data from January 2016 to December 2019 from Taiwan’s National Health Insurance (NHI) Research Database (NHIRD). The follow-up duration was from the index date to December 31, 2020. The NHIRD contains registration files and the original claims data of all NHI beneficiaries (i.e., approximately 27.38 million individuals). All NHIRD data, which are encrypted to ensure beneficiaries’ privacy, include detailed outpatient and inpatient claims information such as patient identification number; birth date; sex; diagnostic codes according to International Classification of Diseases, Ninth Revision, Clinical Modification ( ICD-9-CM ) and International Classification of Diseases, Tenth Revision, Clinical Modification ( ICD-10-CM ); treatment information; medical costs; dates of hospital admission and discharge; and date of death [ 17 , 18 , 19 , 20 , 21 ]. All data sets were interlinked using patient identification numbers. Our protocols were reviewed protocols were reviewed and approved by the Institutional Review Board of Tzu-Chi Medical Foundation (IRB109-015-B).
I would like to clarify that informed consent was waived in our study. This decision was made in accordance with the Personal Information Protection Act, as the data sets used in our research fall under its provisions.
We selected 254,222 elderly patients aged ≥ 60 years who underwent major elective inpatient surgery; these old-age patients required general, epidural, or spinal anesthesia and hospitalization for more than 1 day between 2016 and 2019 in Taiwan. The evaluation of CT scans was limited to the 12-month preoperative period. Among the selected patients, 12,158 patients with a diagnosis of sarcopenia and 242,067 without a diagnosis of sarcopenia were categorized into the sarcopenia and nonsarcopenia groups, respectively (Supplemental Table 1 ). Before 2016, because of a lack of consensus regarding the definition of sarcopenia, a variety of diagnostic criteria were used [ 22 ]. In October 2016, the US Centers for Disease Control and Prevention formally recognized sarcopenia as a disease and coded it as M62.84 in ICD-10-CM [ 23 ]. We defined sarcopenia according the ICD-10-CM code after 2016 [ 17 ]. At least two claims for patients with a principal diagnosis of sarcopenia within the 12-month preoperative period were defined as the criteria for sarcopenia diagnosis. In Taiwan, sarcopenia was coded according to the results of a previous Taiwan study [ 24 ]; sarcopenia was defined as the skeletal muscle mass index (SMI) of 2 standard deviations or more below the normal sex-specific mean values for young persons. The date of onset of diabetes was regarded as the index date. The SMI was calculated using the following formula: SMI = L3 skeletal muscle cross-sectional area (cm 2 )/height 2 (m 2 ), which was measured from computed tomography images [ 25 ].
After adjustment for confounders, we used a multivariate logistic regression model to assess 30-day or 90-day postoperative complications onset from the index date (surgical date) in patients with and without preoperative sarcopenia. To reduce the effects of potential confounders when comparing adverse postoperative outcomes between the sarcopenia and nonsarcopenia groups, we matched all patients through PSM according to the following variables: age, sex, income levels, urbanization, coexisting medical conditions, hospital level, type of anesthesia, ASA score, and surgical type (Table 1 ). We matched the cohorts at a ratio of 1:4 using a greedy matching method, and the covariates were matched within a caliper with a propensity score of 0.2 [ 26 ]. Comorbidities were determined according to ICD-9-CM codes in the main diagnosis records of inpatients or were defined if the number of outpatient visits was ≥ 2 within 1 year. Comorbidities that occurred 2 years before the index date were included in this study.
Continuous variables are presented as means ± standard deviations where appropriate. A PSM ratio of 1:4 was used for the preoperative sarcopenia and nonsarcopenia groups; this ratio is commonly used to select controls with identical background covariates to minimize the differences among participants (we considered using controls based on previous studies) [ 27 , 28 , 29 , 30 , 31 , 32 ]. A multivariate logistic regression model was used to analyze postoperative complications in surgical patients with and without preoperative sarcopenia [ 33 ]. Using multivariate logistic regression analysis, we calculated odd ratios (ORs) with 95% confidence intervals (CIs) to determine whether preoperative sarcopenia is a potential independent predictor of 30-day or 90-day postoperative complications.
Eight major postoperative complications were monitored [ 28 ].: acute myocardial infarction, acute renal failure, deep-wound infection pneumonia, postoperative bleeding, pulmonary embolism, septicemia, and stroke. In our study, we utilized the Clavien Dindo classification system to categorize and describe postoperative complications, focusing on Grade 2 or higher complications [ 34 ]. The primary outcomes of this study were the complications and subsequent overall in-hospital mortality within 30 days after index surgery [ 27 , 28 , 29 , 30 , 31 , 32 ]. Studies have suggested that events recorded within 90 days of surgery are also postoperative complications [ 35 , 36 , 37 , 38 , 39 ].
We used χ 2 tests to analyze the descriptive parameters of demographic characteristics and coexisting medical conditions in the comparison of postoperative complications and death rates of patients with and without preoperative sarcopenia. Continuous variables were analyzed using t tests to compare the differences between patients with sarcopenia and controls. Multivariate logistic regression was used to analyze 30-day and 90-day postoperative complications and mortality between surgical patients with or without sarcopenia through the calculation of the adjusted ORs (aORs) with 95% CIs, with adjustment for age, sex, income level, urbanization, coexisting medical conditions, hospital level, type of anesthesia, ASA score, and surgical type. The logistic regression model’s goodness-of-fit was comprehensively assessed using both the Hosmer-Lemeshow test and the Omnibus test. The Hosmer-Lemeshow test evaluated the agreement between observed and expected outcomes across subgroups, while the Omnibus test assessed the overall significance of the model. These model fit assessments, including the results of the Hosmer-Lemeshow test and Omnibus test, ensured the validity and appropriateness of our logistic regression model. The statistical analysis software program V.9.4 (SAS Institute, Cary, North Carolina, USA) was used for data analyses; the differences between the groups were considered significant if two-sided P values were < 0.05.
The data of 60,790 surgical patients (i.e., 12,158 and 48,632 in the sarcopenia and nonsarcopenia groups, respectively) were included in this study for further analysis; their characteristics are listed in Table 1 . After frequency matching, the between-group differences in age, sex, income levels, urbanization, coexisting medical conditions, hospital levels, types of anesthesia, ASA scores, and surgical types were nonsignificant. The confounders (before matching) in the sarcopenia group significantly differed from those in the nonsarcopenia group ( p < .001; Supplemental Table 1 ). Compared with the nonsarcopenia group, the sarcopenia group had more individuals who were older, were female, had a low income, were rural residents, had more coexisting medical conditions, received surgery at medical centers, and received general anesthesia (Supplemental Table 1 ).
Patients with sarcopenia exhibited higher rates of 30-day postoperative complications, including postoperative pneumonia (1.18% vs. 0.93%; P = .0134), postoperative bleeding (0.09% vs. 0.04%; P = .0420), septicemia (0.76% vs. 0.53%; P = .0028), and overall complications (6.85% vs. 5.62%; P = .0162; Table 2 ). The 30-day postoperative mortality rates for surgical patients with and without sarcopenia were 1.21% and 0.94%, respectively ( P = .0085). Moreover, patients with sarcopenia exhibited higher rates of 90-day postoperative complications, including postoperative pneumonia (2.23% vs. 1.63%; P < .0001), postoperative bleeding (0.13% vs. 0.07%; P = .0267), septicemia (1.50% vs. 0.92%; P < .0001), and overall complications (8.85% vs. 7.95%; P = .0111). The 90-day postoperative mortality rates for surgical patients with and without sarcopenia were 2.08% and 1.38%, respectively ( P < .0001).
After adjustment for age, sex, income levels, urbanization, coexisting medical conditions, hospital levels, types of anesthesia, ASA scores, and surgical types, our multivariate logistic regression analyses revealed that surgical patients with preoperative sarcopenia were at significantly higher risk of 30-day postoperative mortality (aOR = 1.25; 95% CI 1.03 to 1.52) and 30-day major complications, including postoperative pneumonia (aOR = 1.15; 95% CI = 1.00-1.40), postoperative bleeding (aOR = 2.18; 95% CI = 1.04–4.57), septicemia (aOR = 1.31; 95% CI = 1.03–1.66), and overall complications (aOR = 1.13; 95% CI = 1.00-1.46). In addition, surgical patients with sarcopenia were at significantly higher risk of 90-day postoperative mortality (aOR = 1.50; 95% CI = 1.29–1.74) and 90-day major complications, including postoperative pneumonia (aOR = 1.27; 95% CI = 1.10–1.47), postoperative bleeding (aOR = 1.90; 95% CI = 1.04–3.48), septicemia (aOR = 1.52; 95% CI = 1.28–1.82), and overall complications (aOR = 1.24; 95% CI = 1.08–1.42; Table 3 ).
Figure 1 illustrates the cumulative risks of 30-day or 90-day postoperative mortality and complications in matched patients with and without sarcopenia. The cumulative 30-day postoperative mortality was significantly higher in the sarcopenia group than in the nonsarcopenia group ( P < .0001; Fig. 1 A), and the cumulative overall 30-day postoperative complications were significantly higher in the sarcopenia group than in the nonsarcopenia group ( P < .0001; Fig. 1 B). Moreover, the Kaplan–Meier curves revealed that the cumulative 90-day postoperative mortality and overall complications were significantly lower in the sarcopenia group than in the nonsarcopenia group ( P < .0001; Fig. 2 ).
Kaplan–Meier Estimates of 30-d Postoperative Mortality and 30-d Postoperative Complications Among Surgical Patients With and Without Sarcopenia. ( A ) 30-d Postoperative Mortality; ( B ) 30-d Overall Postoperative Complications
Kaplan–Meier Estimates of 90-d Postoperative Mortality and 90-d Postoperative Complications Among Surgical Patients With and Without Sarcopenia. ( A ) 90-d Postoperative Mortality; ( B ) 90-d Overall Postoperative Complications
Clinically, many patients with sarcopenia experience various challenges and severe complications of surgery [ 40 ]. However, the association of preoperative sarcopenia with adverse postoperative outcomes and mortality is unclear [ 13 , 14 , 15 , 16 ]. To the best of our knowledge, the present study is the first and the largest PSM-based comparative study on 30-day and 90-day adverse postoperative outcomes and mortality among patients with and without preoperative sarcopenia. This retrospective, real-world data-derived, population-based PSM cohort study revealed that preoperative existing sarcopenia is an independent risk factor for 30-day and 90-day adverse postoperative outcomes, such as postoperative pneumonia, postoperative bleeding, and septicemia, and preoperative sarcopenia is associated with increased 30-day and 90-day postoperative mortality among patients receiving major surgery. Multivariate logistic regression analyses revealed that surgical patients with preoperative sarcopenia were at significantly higher risk of 30-day postoperative mortality (aOR = 1.25; 95% CI = 1.03–1.52) and 30-day major complications, including postoperative pneumonia (aOR = 1.15; 95% CI = 1.00-1.40), postoperative bleeding (aOR = 2.18; 95% CI = 1.04–4.57), septicemia (aOR = 1.31; 95% CI = 1.03–1.66), and overall complications (aOR = 1.13; 95% CI = 1.00-1.46). In addition, surgical patients with sarcopenia were at significantly higher risk of 90-day postoperative mortality (aOR = 1.50; 95% CI = 1.29–1.74) and 90-day major complications, including postoperative pneumonia (aOR = 1.27; 95% CI = 1.10–1.47), postoperative bleeding (aOR = 1.90; 95% CI = 1.04–3.48), septicemia (aOR = 1.52; 95% CI = 1.28–1.82), and overall complications (aOR = 1.24; 95% CI = 1.08–1.42). Our results provide valuable comprehensive information on postoperative complications, especially postoperative pneumonia, postoperative bleeding, and postoperative septicemia, among patients with sarcopenia receiving surgery. Establishing a comprehensive protocol to prevent the aforementioned postoperative complications that contribute to surgical mortality can be valuable to future research.
Several reports have indicated similar outcomes [ 41 , 42 , 43 , 44 ], suggesting an association between preoperative sarcopenia and increased postoperative complications [ 41 , 42 , 43 , 44 ]. In our extensive investigation, we explored the impact of preoperative sarcopenia on postoperative outcomes within a cohort of 254,222 elderly patients (≥ 60 years) undergoing major elective inpatient surgery in Taiwan between 2016 and 2019. Utilizing Taiwan’s NHIRD, which includes detailed claims data for approximately 27.38 million individuals, our study stands out for its large cohort size, facilitating robust statistical analyses. Unlike earlier studies that employed diverse diagnostic criteria for sarcopenia, our research defined sarcopenia post-2016 using the ICD-10-CM code M62.84 and incorporated specific criteria based on the SMI derived from CT scans. This nuanced approach allows for a more precise identification of sarcopenic patients. Furthermore, our study employed PSM and multivariate logistic regression to account for potential confounders, ensuring a meticulous analysis of 30-day and 90-day postoperative complications. The investigation of eight major complications, including acute myocardial infarction, acute renal failure, deep-wound infection pneumonia, postoperative bleeding, pulmonary embolism, septicemia, and stroke, adds granularity to the understanding of the outcomes. Furthermore, the concentration on individuals aged 60 and above, along with the meticulous matching of different surgical procedures through PSM, distinguishes our approach. Unlike previous studies primarily focusing on specific surgical types, such as cardiac or abdominal surgery [ 43 , 44 ], our research expands the scope and enhances external validity due to a larger and more diverse sample [ 41 , 42 , 43 , 44 ]. Consequently, our conclusions elucidate a higher incidence of surgical complications among elderly individuals with sarcopenia, providing unique insights beyond the existing literature. Importantly, we extend our analysis beyond the conventional 30-day acute complications to include 90-day subacute complications, a novel contribution to the field. This study significantly advances our understanding of the intricate relationship between sarcopenia and postoperative outcomes, making a substantial and novel addition to the existing literature [ 41 , 42 , 43 , 44 ]. Our investigation not only scrutinizes acute complications within the conventional 30-day timeframe but extends its analysis to encompass subacute complications occurring within 90 days—a novel aspect absent in prior literature [ 41 , 42 , 43 , 44 ]. This extended timeframe provides a more comprehensive understanding of the postoperative complications associated with sarcopenia in the elderly, offering unique insights and a substantial addition to the existing literature.
The primary endpoints of our study were centered on complications and overall in-hospital mortality within 30 days following the index surgery, as supported by relevant literature [ 27 , 28 , 29 , 30 , 31 , 32 ]. Recognizing that postoperative events extend beyond the traditional 30-day window, recent studies have advocated for an extended observation period of 90 days to capture a more comprehensive spectrum of postoperative complications [ 35 , 36 , 37 , 38 , 39 ]. Specifically, the 90-day postoperative mortality metric has gained prominence as a robust measure of surgical quality, particularly for procedures involving the digestive tract or the head and neck [ 35 , 36 , 37 , 38 , 39 ]. Given the evolving understanding of the prolonged impact of surgery, we designated 90-day postoperative complications as a primary outcome in our study. This timeframe allows for a nuanced assessment of acute and subacute surgical complications, providing a more comprehensive perspective on patient outcomes. To maintain consistency with established practices and enhance comparability with prior research, we adhered to the definition of 30-day and 90-day in-hospital postoperative mortality as utilized in previous studies [ 27 , 29 , 30 , 31 , 32 , 35 , 36 , 37 , 38 , 39 ]. Consequently, patients who succumbed on the 91st day or later post-hospitalization were considered alive in our study, and those who died outside the hospital within 90 days were not included in the mortality outcome. In conclusion, the choice of assessing 30- and 90-day postoperative complications aligns with contemporary views on capturing the continuum of surgical outcomes, offering a more nuanced understanding of acute and subacute complications associated with the procedures under investigation.
A patient with sarcopenia receiving elective surgery is a patient with certain systemic imbalances and a worse biological reserve, which may contribute to a poor postoperative prognosis; this finding is consistent with a previous study finding [ 45 ]. Moreover, many risk factors are closely related to sarcopenia, for example, increasing age, malnutrition, alcoholism, smoking, insomnia, and chronic diseases, which often affect surgical prognosis and cause postoperative death [ 46 , 47 , 48 ]. Nevertheless, after matching for age, sex, income level, urbanization, coexisting medical conditions, hospital level, type of anesthesia, ASA score, and surgical type, sarcopenia is still an independent risk factor for 30-day and 90-day postoperative pneumonia, bleeding, septicemia, overall surgical complications, and mortality (Tables 2 and 3 ). In addition, not only the ORs of 30-day surgical complications and mortality but also the aORs of 90-day surgical complications and mortality were highly significant (Table 3 ; Fig. 2 ). The subacute surgical complications (90 d) may also be critical in patients with sarcopenia receiving surgery. Based on the outcomes of 30-day and 90-day surgical complications, patients with sarcopenia experience not only acute surgical complications but also subacute surgical complications after receiving elective surgery. The adverse outcomes of surgery in patients with sarcopenia do not alleviate even 30 days after surgery (Figs. 1 and 2 ).
The influence of sarcopenia on the prognosis of surgery is still unclear because of the small sample size, different definitions of sarcopenia, and different surgical types [ 10 , 11 , 13 , 14 , 15 , 16 , 49 , 50 , 51 , 52 , 53 , 54 , 55 ]. Thus far, no study with sufficient sample size or with appropriate matching has investigated the association of sarcopenia with 30-day and 90-day surgical complications and mortality after elective surgery. To the best of our knowledge, this is the first study to use the latest definition of sarcopenia based on ICD-10 and to demonstrate 30-day and 90-day adverse outcomes of surgery in patients with sarcopenia and nonsarcopenia receiving elective surgery. According to our literature review, studies have not compared 30-day and 90-day surgical complications between sarcopenia and nonsarcopenia groups. Our study is the first to demonstrate that patients with sarcopenia exhibited significantly increased rates of 30-day and 90-day adverse outcomes, including postoperative pneumonia, bleeding, septicemia, and mortality after elective surgery.
Among various adverse outcomes after major surgery, postoperative septicemia is one of the key factors leading to the death of patients with sarcopenia [ 56 , 57 , 58 , 59 ]. Our findings indicated that the incidence of 30-day and 90-day postoperative septicemia was significantly higher among patients with sarcopenia than among those without sarcopenia (Tables 2 and 3 ). The high incidence of postoperative septicemia in sarcopenia patients receiving surgery can be attributed to low immunity compared with that of nonsarcopenia patients [ 60 , 61 ]. Muscle fibers can produce cytokines and interleukins, inhibiting the secretion of tumor necrosis factor and mediating insulin resistance [ 62 , 63 ]. Sarcopenia reduces cellular immune function, increases the level of proinflammatory factors, and increases the possibility of infection in the body [ 60 , 61 ]. Moreover, the level of glutamine, which is an activator of lymphocytes and monocytes, is significantly reduced in patients with sarcopenia, thereby partly weakening their immunity [ 64 ]. Studies have suggested that sarcopenia may be one of the predictors of infection after colon cancer surgery [ 11 ].
Decreased immunity in patients with sarcopenia not only increases the possibility of postoperative infection but also increases the incidence of postoperative pneumonia [ 60 , 61 , 65 ]. In addition, patients with sarcopenia receiving surgery may experience difficulty in sputum removal and a high incidence of choking or aspiration pneumonia due to muscular weakness [ 66 , 67 ]. Soma et al. reported that preoperative sarcopenia in patients with esophageal cancer increases the risk of postoperative respiratory disease [ 68 ]; this is consistent with our findings. The increase in postoperative pneumonia may be related to the decrease in skeletal muscle mass and the weakening of respiratory and swallowing muscles in patients with sarcopenia [ 66 , 67 ]. Jain et al. demonstrated that short-term resistance exercise training and protein supplementation before surgery can increase the mass and strength of skeletal muscles and reduce fat content, thereby improving immunity and reducing the incidence of postoperative pulmonary complications [ 69 ]. Therefore, preoperative sarcopenia, swallowing function, and respiratory muscle training should be improved before elective surgery to decrease the incidence of postoperative pneumonia, other surgical complications, and mortality.
Our study discovered that patients with sarcopenia had a significantly increased incidence of 30-day and 90-day postoperative bleeding. To the best of our knowledge, no study has reported that sarcopenia directly alters the coagulation system; however, large retrospective studies have demonstrated that malnutrition can lead to postoperative bleeding in patients undergoing colorectal resection and pancreatic surgery, increase the risks of respiratory failure or infection, and even increase the mortality rate of patients [ 70 , 71 ].
The present study used data from the NHIRD, which reliably records the detailed medical information of Taiwanese patients, and this database has been used in many high-quality studies [ 17 , 20 , 21 , 27 , 28 ]. Furthermore, a large PSM-based design was employed in the comparative study to maintain balance among the confounders of the case and control groups—all in the absence of bias (Table 1 ). However, this study has a few limitations. First, PSM cannot control factors that are not accounted for in the model, and it is predicated on an explicit selection bias of the factors that can be matched. Second, because all patients were enrolled from an Asian population, the corresponding ethnic susceptibilities in non-Asian populations are unclear. However, no significant differences in the postoperative adverse outcomes and mortality have been reported between Asian and non-Asian populations; the results should be cautiously extrapolated to non-Asian populations. Third, another limitation of this study pertains to the diagnosis of sarcopenia, which relies solely on the availability of the ICD code. Consequently, if an individual is unintentionally omitted from receiving the sarcopenia code, they are categorized as not having sarcopenia. We acknowledge that this approach may result in potential underestimation. Recognizing this limitation, we emphasize the importance of conducting further prospective studies to yield more accurate and comprehensive results in this area.
We demonstrated that sarcopenia is an independent risk factor for 30-day and 90-day adverse postoperative outcomes such as postoperative pneumonia, bleeding, septicemia, and mortality after elective surgery. Therefore, preoperative sarcopenia, swallowing function, and respiratory muscle training should be corrected before elective surgery to reduce the incidence of postoperative complications that contribute to the decrease in surgical mortality.
The datasets essential for supporting the conclusions of this study are provided within the manuscript and its supplementary files.
Adjusted odds ratio
Confidence interval
International Classification of Diseases, Ninth Revision, Clinical Modification
International Classification of Diseases, Tenth Revision, Clinical Modification
Propensity score matching
National Health Insurance Research Database
American Society of Anesthesiology
Standard deviation
Standardized mean difference
Interquartile range
National Health Insurance
Skeletal muscle mass index
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The work of Szu-Yuan Wu is supported by the Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, under funding numbers 11001, 11010, 11013, and 11103 and the work of Jiaqiang Zhang is supported by the National Key Research and Development Program of China,under funding number 2023YFC2506903.
Yitian Yang and Mingyang Sun have contributed equally to this study (joint primary authors).
Szu-Yuan Wu and Jiaqiang Zhang have contributed equally to this study (joint Correspondence authors).
Department of Anesthesiology and Perioperative Medicine, Henan Provincial People’s Hospital, People’s Hospital of Zhengzhou University, Zhengzhou, China
Yitian Yang, Mingyang Sun & Jiaqiang Zhang
Graduate Institute of Business Administration, College of Management, Fu Jen Catholic University, Taipei, Taiwan
Wan-Ming Chen & Szu-Yuan Wu
Artificial Intelligence Development Center, Fu Jen Catholic University, Taipei, Taiwan
Department of Food Nutrition and Health Biotechnology, College of Medical and Health Science, Asia University, Taichung, Taiwan
Szu-Yuan Wu
Big Data Center, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
Division of Radiation Oncology, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
Department of Healthcare Administration, College of Medical and Health Science, Asia University, Taichung, Taiwan
Cancer Center, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
Centers for Regional Anesthesia and Pain Medicine, Taipei Municipal Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
Department of Management, College of Management, Fo Guang University, Yilan, Taiwan
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The collaborative effort of the authors resulted in the conception and design of the study, led by Yitian Yang, Mingyang Sun, Wan-Ming Chen, Szu-Yuan Wu, and Jiaqiang Zhang. Financial support for this work was provided by the Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, with funding numbers 11001, 11010, 11013, and 11103, benefiting the research of Szu-Yuan Wu. The comprehensive collection and assembly of data were carried out by Yitian Yang, Szu-Yuan Wu, and Jiaqiang Zhang. The crucial tasks of data analysis and interpretation were undertaken by Jiaqiang Zhang and Szu-Yuan Wu. Administrative support was provided by Szu-Yuan Wu. The manuscript itself was written collaboratively by Yitian Yang, Mingyang Sun, Wan-Ming Chen, Szu-Yuan Wu, and Jiaqiang Zhang. Lastly, the final approval of the manuscript was granted by all authors, reflecting their unified contributions and dedication to the study’s completion.
Correspondence to Szu-Yuan Wu or Jiaqiang Zhang .
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The incidence of recurrent hernia after radical resection of prostate cancer is high, so this article discusses the incidence and risk factors of inguinal hernia after radical resection of prostate cancer.
This case control study was conducted in The First People’s Hospital of Huzhou clinical data of 251 cases underwent radical resection of prostate cancer in this hospital from March 2019 to May 2021 were retrospectively analyzed. According to the occurrence of inguinal hernia, the subjects were divided into study group and control group, and the clinical data of each group were statistically analyzed, Multivariate Logistic analysis was performed to find independent influencing factors for predicting the occurrence of inguinal hernia. The Kaplan-Meier survival curve was drawn according to the occurrence and time of inguinal hernia.
The overall incidence of inguinal hernia after prostate cancer surgery was 14.7% (37/251), and the mean time was 8.58 ± 4.12 months. The average time of inguinal hernia in patients who received lymph node dissection was 7.61 ± 4.05 (month), and that in patients who did not receive lymph node dissection was 9.16 ± 4.15 (month), and there was no significant difference between them ( P > 0.05). There were no statistically significant differences in the incidence of inguinal hernia with age, BMI, hypertension, diabetes, PSA, previous abdominal operations and operative approach ( P > 0.05), but there were statistically significant differences with surgical method and pelvic lymph node dissection ( P < 0.05). The incidence of pelvic lymph node dissection in the inguinal hernia group was 24.3% (14/57), which was significantly higher than that in the control group 11.8% (23/194). Logistic regression analysis showed that pelvic lymph node dissection was a risk factor for inguinal hernia after prostate cancer surgery (OR = 0.413, 95%Cl: 0.196–0.869, P = 0.02). Kaplan-Meier survival curve showed that the rate of inguinal hernia in the group receiving pelvic lymph node dissection was significantly higher than that in the control group ( P < 0.05).
Pelvic lymph node dissection is a risk factor for inguinal hernia after radical resection of prostate cancer.
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Prostate cancer is a common malignant tumor in urology, which occurs in the prostate epithelial tissue, There are an average of 190,000 new cases of prostate cancer each year and about 80,000 deaths worldwide each year [ 1 , 2 ]. In recent years, the incidence of prostate cancer has increased year by year, seriously affecting the health and quality of life of patients [ 3 ]. Worldwide, the incidence of prostate cancer is second only to lung cancer, and its death rate ranks 7th among male cancer causes [ 4 ]. Radical resection of prostate cancer (RP) is the main means for the treatment of prostate cancer, and the surgical methods are generally divided into open radical resection of prostate cancer (RRP) and minimally invasive radical resection of prostate cancer, the latter including laparoscopic radical resection of prostate cancer (LRP) and robot-assisted laparoscopic radical resection of prostate cancer (RALP) [ 5 , 6 , 7 ].
Inguinal hernia (IH) is a relatively common disease in clinic, which is caused by increased abdominal pressure, thinning of abdominal wall, and bulging of abdominal organs. Inguinal hernias include direct hernias, oblique hernias and femoral hernias [ 8 ]. At the onset, lumps protruding outward from the inguinal region can be seen. If the intestines cannot return to the abdominal cavity in time, it is easy to cause intestinal necrosis, intestinal obstruction, intestinal perforation and other complications, which may endanger the life safety of patients in severe cases [ 9 , 10 ].
With the extensive development of radical resection of prostate cancer in various hospitals, the problem of postoperative inguinal hernia has gradually attracted the attention of urologists. The previously reported incidence of IH after radical prostate cancer surgery was approximately 13.7% [ 11 ]. A study by Nagatani S et al. showed that the incidence of inguinal hernia after radical prostate cancer surgery was 7-21%, most of which occurred within 2 years after surgery [ 12 ]. A study by Stranne J et al. showed that the cumulative risk of IH occurrence within 48 months in open radical resection for prostate cancer group and non-surgical group was 12.2% and 5.8%, respectively [ 13 ]. Most cases of IH require surgery due to pain, discomfort, and incarceration and are considered an advanced complication of radical resection of prostate cancer. The adhesion after radical resection of prostate cancer also increases the difficulty of hernia repair. Therefore, urologists need to be concerned not only about the risk of urinary incontinence and erectile dysfunction after radical resection of prostate cancer, but also about the occurrence of IH.
In recent 10 years, many scholars around the world have studied the risk factors of inguinal hernia after radical prostate cancer surgery. Currently, most of the studies believe that anastomotic stenosis, previous history of inguinal hernia, and patent processus vaginalis are risk factors, However there is no consensus on the risk of lymph node dissection. For example, Niitsu H et al. believed that pelvic lymph node dissection during radical prostate cancer operation might damage the pectineal foramina, thereby increasing the risk of inguinal hernia [ 14 ]. Contrary to the results of Johan Stranne’s study, the author suggested that previous incidence of inguinal hernia and advanced age increased the risk of inguinal hernia after radical prostate cancer surgery, and pelvic lymph node dissection was not a significant risk factor [ 15 ]. There is also no consistent conclusion on the influence of BMI, age and surgical method.
Therefore, in order to further investigate the risk factors of inguinal hernia after radical prostate cancer surgery, especially the correlation between pelvic lymph node dissection and inguinal hernia, this study was conducted. This study retrospectively analyzed the clinical data of 251 patients who underwent radical resection of prostate cancer in our hospital from March 2019 to May 2021, and investigated the risk factors of postoperative inguinal hernia. It is reported as follows:
The objective of this study was to explore the incidence and risk factors of inguinal hernia after radical resection of prostate cancer, which provides reference for further research and guide the clinician to choose the appropriate surgical method according to the patient’s condition.
The patient was also examined by B-ultrasound every 3 months at the outpatient PSA review to verify the occurrence of inguinal hernia. The subjects were divided into the inguinal hernia group (study group) and the non-inguinal hernia group (control group), If the diagnosis of inguinal hernia occurred, the follow-up was completed, and the type and time of inguinal hernia were recorded; otherwise, the follow-up was 2 years, and the relevant clinical parameters of each group were statistically analyzed (age, BMI, hypertension, diabetes mellitus, PSA value, previous abdominal operations, operation methods, operative approach, pelvic lymph node dissection)and the correlation between these parameters and the occurrence of inguinal hernia was analyzed, and the risk factors of inguinal hernia were found by Logistic regression analysis. According to the occurrence and time of inguinal hernia, Kaplan-Meier survival curve was drawn to compare the differences between the two groups.
The content of this study has been approved by the Ethics Committee of our hospital(approval number, 2,018,137). All patients signed informed consent forms. This is the protocol was registered on the Chinese Clinical Trial Registry. The study is planned to begin in mid-March 2019 and is planned to end by May 2021.
Patients who received radical surgery for prostate cancer in Huzhou First People’s Hospital from March 2019 to May 2021; PSA was reviewed every 3 months after surgery, and check the inguinal area for protruding masses. Complete the 2-year follow-up plan.
Patients with inguinal hernia before operation; patients with prior inguinal hernia surgery.
SPSS 21.0 statistical software was used for statistical processing, the research data followed normal distribution, and the measured data were represented by X ± S. P < 0.05 was considered statistically significant.
From March 2019 to May 2021, 318 cases of radical prostatectomy were performed in our hospital, during the follow-up period, a total of 28 cases died of other diseases, a total of 39 cases were lost to follow-up or clinical data were incomplete, and a total of 251 cases were finally followed up. There were no significant differences in age, BMI, hypertension, diabetes, PSA, previous abdominal operations and operative approach between the two groups ( P > 0.05), while there were significant differences in surgical method and pelvic lymph node dissection ( P < 0.05). The incidence of pelvic lymph node dissection in the inguinal hernia group 24.3% (14/57) was significantly higher than that in the control group 11.8% (23/194). See Table 1 for details.
Multivariate Logistic regression analysis of risk factors showed that pelvic lymph node dissection was a risk factor for inguinal hernia after prostate cancer surgery (OR =0.413, 95%Cl: 0.196-0.869, P = 0.02). There was no statistical significance in age, BMI, hypertension, diabetes, PSA value, previous abdominal operations, operation method, operative approach were not risk factors for inguinal hernia ( P > 0.05). See Table 2 for details.
The cases of inguinal hernia were grouped according to whether or not they had received pelvic lymph node dissection. The incidence and time of inguinal hernia in the two groups were recorded, and the Kaplan-Meier survival curve was drawn. The overall incidence of inguinal hernia after radical resection of prostate cancer was 14.7% (37/251), There were 26 cases with indirect hernia, accounting for 70.2% (26/37), 21.6% (8/37) with direct hernia, 8.2% (3/37) with oblique hernia and direct hernia, and the mean time of occurrence was 8.58 ± 4.12 months. The average time of inguinal hernia was 7.61 ± 4.05 (month) for those who received lymph node dissection and 9.16 ± 4.15 (month) for those who did not receive lymph node dissection, and there was no significant difference between them ( P > 0.05). The incidence of inguinal hernia in the group receiving pelvic lymph node dissection was significantly higher than that in the control group ( P < 0.05). See Fig. 1 for details.
Survival curve of pelvic lymph node dissection and inguinal hernia (month)
In recent years, the incidence of prostate cancer has increased year by year, seriously affecting the health and quality of life of patients, the complications after radical prostate cancer surgery mainly include urinary incontinence and sexual dysfunction, but inguinal hernia is also one of the common complications [ 16 ]. Liu L et al. found that open radical resection for prostate cancer technique and advanced patient age, especially those over 80 years old, are associated with a higher incidence of IH. Appropriate prophylaxis during surgery should be evaluated in high-risk patients [ 17 ].In some regional studies, low BMI has been identified as a risk factor for IH, and the risk threshold for BMI has not been determined, which is about BMI < 25 kg/m2 [ 18 ]. However, a number of studies have found that low BMI does not increase the risk of postoperative IH [ 19 , 20 ]. At present, there is no uniform conclusion on the risk of IH between open radical resection for prostate cancer and laparoscopic radical prostatectomy. The study of Alder R scholars believed that the incidence of IH after laparoscopic radical prostatectomy was relatively low [ 21 ], while Otaki T’s study shows that the incidence of IH after laparoscopic radical prostatectomy is 7.3% and that of open radical resection for prostate cancer is 8.4%, showing no statistical difference between them [ 20 ]. There is no consensus on whether pelvic lymph node dissection is a risk factor for inguinal hernia [ 14 , 15 ]. In short, the specific mechanism of inguinal hernia after radical prostate cancer surgery is unclear.
This study retrospectively analyzed the clinical data of 251 cases treated in our hospital, and found that the overall incidence of inguinal hernia was 14.7% (37/251), which was consistent with most of the current research results. We also found that the average time of occurrence of inguinal hernia after surgery was 8.58 ± 4.12 months, which provided certain guidance for our postoperative follow-up time.
In this study, through Logistic multivariate analysis, it was found that pelvic lymph node dissection was a risk factor for inguinal hernia after prostate cancer surgery (OR = 0.413, 95%Cl: 0.196–0.869, P = 0.02). There was no statistical significance in age, BMI, hypertension, diabetes, PSA value, previous abdominal operations, operation method, operative approach and the occurrence of inguinal hernia after prostate cancer surgery ( P > 0.05),but there were statistically significant differences with surgical method and pelvic lymph node dissection ( P < 0.05). Therefore, the advantages and disadvantages of pelvic lymph node dissection should be reasonably evaluated for low-medium-risk prostate cancer patients, so as to avoid the occurrence of inguinal hernia. By drawing Kaplan-Meier survival curve, it was found that the rate of inguinal hernia in the group receiving pelvic lymph node dissection was significantly higher than that in the control group. Some studies believe that pelvic lymph node dissection during radical resection of prostate cancer operation will cause postoperative scar contraction in the inguinal region, resulting in an increase in abdominal pressure outward and downward, resulting in an increase in the incidence of inguinal hernia. Lodding P designed a comparative study between the group of radical resection of prostate cancer plus pelvic lymph node dissection, the group of pelvic lymph node dissection and the group without operation. They found that the incidence of inguinal hernia in the three observation groups was 13.6%, 7.6% and 3.1%, respectively, and the difference between the prostatectomy group and the group without operation was statistically significant. There was no significant difference between the group and pelvic lymph node dissection group. This result implies that pelvic lymph node dissection is an important factor in the development of inguinal hernia [ 22 ]. Another Sun M study compared the incidence of inguinal hernias after radical prostate cancer surgery and pelvic lymph node dissection alone, and showed that the risk of inguinal hernias increased by 6.8% and 7.8% at 5 and 10 years, respectively, in the radical prostate cancer resection group compared with the pelvic lymph node dissection group [ 23 ]. Niitsu H et al. believed that pelvic lymph node dissection during radical resection of prostate cancer might damage the pectineal foramina, while inguinal hernia originated from the defective pectineal foramina [ 14 ].
Shimbo M et al. found that due to prostatectomy and vesicourethral anastomosis, preoperative and postoperative sagittal MRI images showed that the rectovesical excavation (RE) was moved downward by about 2 to 3 cm [ 24 ]. Accordingly, they speculated that due to the displacement of RE, the peritoneum and vas deferens after urethrovesical anastomosis were pulled, which further pulled the opening of the inner ring and caused it to shift medially, which led to the occurrence of postoperative IH. Based on this theory, many scholars have prevented the occurrence of hernia after operation by reducing the tension of peritoneum and vas deferens at the inner ring and ligation and rupture of sheathing process. Several other articles have reported the role of preserving the retropubic space (RS) in preventing IH after radical resection of prostate cancer. Chang KD et al. found that robot-assisted laparoscopic radical prostatectomywith retained Retzius space significantly reduced the incidence of postoperative IH compared with standard robot-assisted laparoscopic radical prostatectomy [ 25 ]. In addition, the study of Matsubara et al. also showed that compared with standard open radical resection for prostate cancer, the incidence of IH after transperineal radical resection of prostate cancer with retained anatomical structures such as the Retzius space was lower [ 26 ]. Therefore, urological surgeons can take some effective measures in the operation to prevent the recurrence of inguinal hernia.
In this study, we identified risk factors for inguinal hernia after pelvic lymphadenectomy for prostate cancer. Other risk factors such as age, BMI, hypertension, diabetes mellitus, PSA value, history of abdominal surgery, operative method, operative approach were not significant in multivariate analysis, which was inconsistent with the results of Iwamoto H et al [ 27 ]. They found that dilatation of the right internal inguinal ring and different manipulation of the medial peritoneal incision of the ventral femoral ring were independent risk factors for IH after laparoscopic radical prostatectomy. The reason why postoperative IH occurs more often on the right side is not known. Alder R et al. found that the incidence of IH after open radical prostate cancer treatment was significantly higher than laparoscopic radical prostate cancer treatment [ 21 ], but our study did not show a difference between the two groups, possibly due to the small number of cases included in open radical prostate surgery.
In summary, the incidence of inguinal hernia after radical prostate cancer surgery is relatively high, and the specific cause is still unclear. Our study shows that pelvic lymph node dissection is a risk factor for inguinal hernia.
The sample size of this study is small, and it belongs to a single-center study, so the representativeness of the research conclusions may not be strong. This time, we followed up the samples for 2 years, which was not long enough and may have overlooked the real incidence of inguinal hernia. In addition, this study is a retrospective study, and the clinical parameters observed are not very comprehensive, which may ignore the influence of other factors on the IH. Because our data is derived from clinical data, some data cannot be detected. These problems need further study by more scholars.
We cannot provide and share our datasets in publicly available repositories because of informed consent for participants as confidential patient data. Data may be obtained from the corresponding author upon reasonable request.
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This work was supported by the following funding: the grant 2019GY23 from Huzhou Science and Technology Bureau Public welfare application research project of China.
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Department of Urology, The First People’s Hospital of Huzhou, #158, Square Road, Huzhou, 313000, China
An-Ping Xiang, Yue-Fan Shen, Xu-Feng Shen & Si-Hai Shao
Department of Urology, Huzhou Key Laboratory of Precise Diagnosis and Treatment of Urinary Tumors, Huzhou, 313000, China
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An-Ping Xiang designed the study and drafted and revised the manuscript, Yue-Fan Shen recorded the patients cases, Xu-Feng Shen participated in the follow-up. An-Ping Xiang and Si-Hai Shao analyzes the data and draw graphs.
Correspondence to Si-Hai Shao .
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The study protocol was approved by the ethics committee of the First People’s Hospital of Huzhou (approval number, 2018137). We have obtained written informed consent from all study participants. All of the procedures were performed in accordance with the Declaration of Helsinki and relevant policies in China.
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Xiang, AP., Shen, YF., Shen, XF. et al. Correlation between the incidence of inguinal hernia and risk factors after radical prostatic cancer surgery: a case control study. BMC Urol 24 , 131 (2024). https://doi.org/10.1186/s12894-024-01493-w
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DOI : https://doi.org/10.1186/s12894-024-01493-w
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Introduction Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery.
Methods and analyses This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways.
Ethics and dissemination This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH—Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals.
Trial registration number Clinical Trials Platform ( https://clinicaltrials.gov/ ) with the number NCT05816798 .
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .
https://doi.org/10.1136/bmjopen-2023-079864
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This protocol is a randomised, placebo, double-blinded controlled trial on photobiomodulation (PBM) treatment for obesity patients suffering from chronic pain.
The PBM protocol will be applied directly in the topography of pain associated with paraspinal stimulation targeting the origin of neural sensitization mechanisms of chronic pain.
Protocols aimed to apply to patients with chronic knee pain who have other comorbidities should be adapted to the particularities of these patients.
Since our sample will be composed of patients with pain with a minimum visual analogue scale of 40, we will include patients with pain ranging from moderate to high grade, which may impact the results, as patients with mild pain may not respond sufficiently to generate a statistical difference between the pre- and post-treatment moments.
The world health panorama has shown a growing concern and allocation of resources to chronic diseases since these are the main reasons for increased disabilities and loss of quality of life worldwide. 1 2 Among these chronic conditions, obesity stands out. The WHO has recognised that obesity has become a public health concern. The Global Burden of Disease Study results showed that high body mass index (BMI) has become a major challenge, as it is directly linked to many health problems, such as cardiovascular, diabetes, kidney and neoplasm diseases. 2 3 In addition, chronic pain affects 33% of obese people and is also more prevalent in obese than non-obese patients. 4
Chronic musculoskeletal pain compromises the performance of daily and practical activities of obese individuals. Furthermore, longitudinal evidence shows that high BMI not only precedes but is also a predictor of knee pain. 5 Underweight individuals (BMI <18.5) had a prevalence of knee pain of 12.1%, those with desirable weight (BMI 18.5 and 24.9) had a prevalence of knee pain of 15.2%, and those with BMI ≧40 had a prevalence of knee pain of 55.7%. 6
In populations with severe obesity, bariatric surgery is indicated to reduce the risk of complications and comorbidities that arise due to excess weight. 7 Nonetheless, for a satisfactory result of bariatric surgery, it is necessary to carry out a pre-surgical rehabilitation programme consisting of therapeutic exercises aimed to improve cardiorespiratory fitness and mobility. 7 However, despite advances in therapeutic techniques aimed for analgesia, due to the chronicity and severity of pain, few advances are made functionally in these pre-surgical programmes, which impact negatively on clinical and functional post-surgical results. 8 The persistence of chronic knee pain in this population becomes a limitation for the individual’s daily activities, in addition to hindering their participation and adherence to the pre-rehabilitation programme for bariatric surgery. 5
Chronic pain does not only refer to pain that persists lasting longer than 3 months but is already well established to be related to central and peripheral neurological sensitization mechanisms with chronic pain, low response to conventional treatments, functional impact and poor prognosis. 9 In chronic pain therapy, the multimodal approach is more effective to control the symptoms. Medications that act on different anatomical sites of the pain pathway are needed. 9
In addition, non-pharmacological measures are also applied in a broad way. The use of cognitive-behavioural measures, exercises, proper nutrition, ergonomic modifications and physical therapies such as electric stimulation or photobiomodulation (PBM) is now considered a fundamental key point in the treatment of chronic pain. 10
PBM is an effective analgesic non-pharmacological therapy, which can be safely and easily applied by a qualified professional. The association of PBM with kinesiotherapy sessions may be a good option to alleviate pain and promote a faster return to functional status. 11–14 PBM refers to a series of therapies, in which non-ionising, non-thermal light beams, including LEDs and lasers in the visible and infrared spectra, are used for the interaction with biological tissues from different objectives. 15 Several possible mechanisms of action have been attributed to PBM such as an increase in endogenous opioids, thermal pain threshold, and local blood circulation, ATP or neurotransmitter production at the cellular level, and oxygen consumption and anti-inflammatory cytokine changes. 15
In this sense, numerous PBM techniques have been used in the treatment of musculoskeletal pain, and clinical studies have investigated its effectiveness with excellent results. 16 Thus, this study aimed to evaluate the effects of PBM on the pain and functionality of obese patients with chronic knee pain undergoing a pre-surgical rehabilitation programme for bariatric surgery, discussing its role as an analgesic therapy and modifier of neurological sensitization mechanisms to the pain pathway.
Study design, protocol registration and recruitment.
This will be a single-centre, superiority, phase II, double-blinded, randomised, two-arm, placebo-controlled clinical trial that will involve obese patients with a referral to bariatric surgery under medical follow-up in the Gastric Surgery Service of the Hospital das Clínicas da Universidade Federal de Goiás (HC-UFG) Brazil). It was registered in the Clinical Trials Platform ( https://clinicaltrials.gov/ ) with the number NCT05816798 and follows SPIRIT reporting guidelines. 17 To achieve adequate participant enrolment to reach the target sample size, participation in the study will be offered to all obese patients in the registry database of the medical group of the hospital with referral to bariatric surgery (BMI of over 40 or over 35 plus systemic disable conditions: sleep apnea, diabetes mellitus, coronary artery disease, arterial hypertension, dyslipidemia). Once identified in the database, the potentially eligible patients for the study will be contacted by the physiotherapists, who will explain the study and verify the interest in participating. If there is interest, evaluations will be made by the principal investigator (PI) to verify the eligibility criteria. Patient enrolment for this pilot study commenced in July 2023. To date, eight patients have been enrolled, with the anticipated pilot study enrolment completed by December 2024.
An initial assessment will be conducted by the PI to assess the eligibility criteria and the signature of the consent form by the included patients.
Inclusion Criteria: Obese patients with chronic knee pain undergoing medical follow-up in the Gastric Surgery Service with an indication for bariatric surgery already performed by the responsible medical team and also submitted to the programme of pre-surgical rehabilitation standard treatment for bariatric surgery at the Physiotherapy Outpatient Clinic of the Hospital. These patients have already received the medical indication of the need to undergo surgery. However, even if the indication for the procedure is already established, as usual in the hospital routine, surgery is not performed immediately. They are submitted to a standard multidisciplinary pre-surgical rehabilitation programme preoperatively.
Patients with chronic pain (>3 months) in the knees bilaterally.
Based on studies by Üstün et al 18 and Matsuse et al 19 , we include obese patients with baseline knee pain assessed by the pain visual analogue scale (VAS) at least 40 at the moment of evaluation, using a 100 mm VAS with 0 representing no pain and 100 representing the worst pain imaginable.
Age: 18 to 70 years.
Agree to sign the Informed Consent Form approved by the local Ethics Committee.
Patients with a diagnosis of rheumatological, systemic inflammatory, knees previous musculoskeletal diseases, neuropathies, infections or tumours at the application site of therapy, severe psychiatric disorders requiring psychiatric care.
Previous use of phototherapy for the same or another indication.
Use of corticosteroids at an immunosuppressive dose (20 mg daily of prednisone or equivalent for at least 14 days) in the last 90 days.
Systemic injections and/or joint infiltrations of corticoids or hyaluronic acid in the last 3 months.
Withdrawal of the Informed Consent form by the participant.
Patients excluded from the queue for bariatric surgery or the pre-surgical rehabilitation programme.
Changes in the analgesic medication used. Changes in the dosages may be tolerated as long as there are no changes in the class of medication. The dosage modifications throughout the study, if they occur, will be described.
Eligible patients will be assigned to groups with a 1:1 allocation rate into two groups. The two groups are the PBM intervention group (use of PBM therapy+pre-surgical rehabilitation standard programme of the hospital) or control group (placebo PBM therapy+pre-surgical rehabilitation standard programme of the hospital). At the time of allocation, opaque envelopes will be identified with sequential numbers with the information on the corresponding group according to the order obtained in the randomisation list by Research Randomiser online software, which generates a sequential randomisation list using random block sizes (eight patients per block). The envelopes will be sealed in numerical order until the moment of study intervention and just immediately before the PBM moment, the researcher responsible for the treatment will open one envelope (without changing the numerical sequence) and perform the indicated procedure (PBM or placebo PBM).
Baseline and final assessments will be conducted by the PI, who will be blinded about the randomisation and allocation of patients. Patients will also be blinded to the randomisation and allocation until the end of the study. The pre-surgical rehabilitation standard treatment will be held by a physiotherapist who is blinded to evaluation data or the treatment group. Another physiotherapist will be responsible for the application of PBM, placebo PBM and by the allocation and randomisation, but is also blinded to evaluation data. Concerning placebo treatment, our participants do not use PBM therapy routinely, and they are not familiar with the procedures or particularities of this therapy, which contributes to their inability to distinguish between regular therapy and placebo therapy. Furthermore, all participants will wear dark protective glasses, which completely block vision (used for eye safety) and contribute to the blinding of using a placebo. The recorded sound that will be used to simulate the use of the equipment (placebo PBM group) is the sound generated by the device itself in use, during its regular operation in the study.
The sample size was calculated based on Matsuse et al 19 in which VAS values were obtained for the control group (61.5±22.8) and the treated group (44.2±19.4), with a reliability of 95%, error of 5% and test detection power of 80%. Considering a VAS change of at least 20% comparing the pre and post-moments in the treatment group, the minimum sample size will be 26 patients per group. Assuming a percentage of 20% of drop-outs, the minimum sample size will be 31 patients per group. 19
1. Pre-surgical rehabilitation standard programme of the hospital
All patients undergoing follow-up at the Gastric Outpatient Clinic of HC-UFG due to severe obesity and who have an indication for bariatric surgery are submitted to a standard multidisciplinary pre-surgical rehabilitation programme for 3 to 6 months preoperatively.
This programme will be maintained for all study patients, for both groups, throughout the study period and includes 2X per week activities of:
Cardiopulmonary physiotherapy: depending on the clinical condition may include deep breathing exercises; hands-on techniques; breathing facilitation exercises; percussions and vibrations; coughing and breathing strategies; circulation exercises; mobility assistance to move safely in bed; and sit up, stand, walk, bed and chair standing exercises to prevent deep vein thrombosis (clots) using the fitness programme.
Kinesiotherapy with global muscle strengthening exercises: depending on the clinical condition, these may include lifting weights, working with resistance bands, climbing stairs, hill walking, cycling, dance, push-ups, sit-ups and squats.
Follow-up with the nutrition team to personalised, one-on-one dietary guidance and counselling.
Follow-up with the psychology team to personalised one-on-one identify barriers, come up with strategies, solve problems and assist the patients in figuring out how they are going to implement some of the needed changes given their individual life circumstance.
2. PBM intervention Group
In addition to the standard treatment described above, the PBM therapy sessions will be carried out in the Physiotherapy Outpatient Clinic of the Hospital, two times per week, for 12 consecutive weeks, just after the pre-surgical rehabilitation standard programme, to improve adherence to intervention protocols. The PBM application points are as follows:
Transcutaneous paravertebral region bilaterally at levels of L3, L4 (iliac crest), L5, S1 and, S2 roots topography, 1 cm lateral to the spinous process, corresponding to the roots levels that innervate the knee joint (totaling 10 paraspinal points).
Knees transcutaneous bilaterally (four points on each knee):
Anteromedial point.
Anterolateral point.
Patellofemoral joint—the apex of the patella.
Patellofemoral-base patellar joint.
The responsible for the application will be present throughout the intervention.
The PBM parameters are described in table 1 and are based on studies by Fernandes et al , Zein et al , and Leal-Junior et al . 11 20 21 They also follow the recommendations of the World Association of Laser Therapy WALT. 20–22
Photobiomodulation parameters
3. Placebo PBM therapy
Placebo group patients will receive the pre-surgical rehabilitation standard programme described above as well as a placebo PBM treatment to mask the treatment. The placebo PBM therapy has the same procedures, number of points and place of application described in the item PBM intervention group; however, the PBM equipment will be turned off. The device activation noise will be recorded and used to mimic the irradiation.
Furthermore, the PBM therapy and placebo PBM therapy will be performed on the same day that the patient is already scheduled to undergo the pre-surgical rehabilitation standard programme of the hospital, therefore not adding extra-hospital visits for the patients.
The primary outcomes evaluated will be pain and functionality through the following outcome measures:
Change from baseline to 12 weeks (after PBM treatment) in the VAS. 23 24 Pain knee was evaluated using a 100 mm VAS with 0 representing no pain and 100 representing the worst pain imaginable.
Change from baseline to 12 weeks (after PBM treatment) in the Brazilian version of Knee Injury and Osteoarthritis Outcome Score Questionnaire 25 .
Secondary outcomes related to the clinical assessment of neurological sensitization of the pain pathway will be evaluated through:
Changes from baseline to 12 weeks (after PBM treatment) in the pressure pain threshold measured bilaterally in the muscles: popliteus, sartorius, quadratus lumborum, rectus femoris, vastus medialis, vastus lateralis, adductor longus, tibialis anterior, peroneus longus, gracilis and supraspinatus ligaments between L1-L2, L2-L3, L3-L4, L4-L5, L5-S1 and S1-S2. 26 27 Pressure is applied perpendicularly to the skin at a speed of 1 kg/s by a digital pressure algometer (Instrutherm TM ) to patients indicate when they start to feel pain.
Changes from baseline to 12 weeks (after PBM treatment) in the the Pinch and Roll Maneauver 26 28 29 at L1, L2, L3, L4, L5, S1 and S2 will be performed bilaterally to assess signs of subcutaneous hyperalgesia.
Other exploratory outcomes are related to knee function and quality of life through the following outcome measures:
Changes from baseline to 12 weeks (after PBM treatment) in the 6 min walk test. 30
Changes from baseline to 12 weeks (after PBM treatment) in the Brazilian version of the SF 36 Quality of Life Scale. 31
Changes from baseline to 12 weeks (after PBM treatment) in the range of motion of the knee joint measured with a goniometer.
The following data will be collected from medical official records for the sample epidemiological clinical data: age, gender, BMI, life habits (alcoholism, smoking, drug use), comorbidities, use of analgesic drugs and doses and knee pain duration.
The schedule of enrolment, interventions, assessments and visits for participants is presented in figure 1 . Figure 2 presents the planned flow chart showing inclusion, randomisation and participation throughout the study.
Participant timeline schedule of enrolment, interventions and assessments.
The planned flow chart showing inclusion, randomisation and participation throughout the study.
An electronic spreadsheet database will be created to preserve the confidentiality of patient data and allow the exchange of information between the researchers of the group. This information will be stored for 5 years after the completion of the study in a digital file by the PI. All research data collected will be saved directly in these electronic files and stored on the research team’s institutional drive server. The system has authentication password tools, access control and activity recording, ensuring security and traceability of data.
The data will be analysed to assess the distribution of demographic data and outcome criteria by the Kolmgorov–Smirnov (KS) and Shapiro–Wilk tests. Variables are reported as means and SD. Comparison of before/after PBM ‘within group’ will be made using paired t-test. Comparison of changes from baseline to the endpoint (treatment vs sham) ‘between groups’, will be made with two-sample t-test. In case of non-normal distribution, comparisons will be made using the Wilcoxon Sign Rank test and Mann–Whitney test for paired and unpaired data, respectively. To analyse the correlation of primary and secondary outcomes the χ2 test or Pearson’s exact test will be used. For all tests, a significance level of α=5% will be established. All analyses will be performed using SPSS statistical software version 28.0 for MAC (IBM Corporation, USA).
Patients or the public were not involved in the design, conduct, reporting or dissemination plans of our research.
This study complies with the ethical research guidelines already approved by the ethics committee of the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee with the number 5.951.619/approval number: 66250922200005078. The participants will only be included after properly obtaining consent and signing the Free and Informed Consent term. All data published or made available will not contain sensitive data that identify the patients. The study will not interfere with the clinical follow-up and medical decisions of the healthcare team or medical routine of patients.
Although the use of PBM devices is safe, the main care should be directed towards avoiding ocular injury (damage to the retina, lens such as cataracts, burns to the cornea and crystalline lens) and skin damage, such as burns, erythema and increased sensitivity. 32 To prevent these side effects, during the interventions, both examiners and patients will be wearing protective eyewear. Moreover, applications will occur after locally cleaning the device and skin. In addition, our clinical team of study has experiences and qualifications in the application of PBM therapies. After each therapeutic session, the patient will be questioned and clinically evaluated for any undesirable or adverse effect of the PBM (Adverse Effects Monitoring Sheet) by the health professional team. If there is any Suspected Unexpected Serious Adverse Reaction, the patient will be removed from the study, and the Ethical Committee will be notified to assess the need to interrupt the intervention/study and/or unblinding patients. If any other medical treatment is necessary, it will be carried out by the hospital medical team. If any adverse event occurs, participants will be withdrawn from the study, and these data will be reported. Any withdrawal or loss of patients due to adverse events will be reported.
The data management plan is available in the Data Management Plan https://dmphub.uc3prd.cdlib.net/dmps/10.48321/D1MW8J
Upon completion of the study, the original clinical non-identifiable collected data stored in the spreadsheets of institutional drive referring to pain, quality of life and functionality assessments will be made available in an open science repository, to collaborate with the scientific community and auditing. The results of this work after the statistical analysis (whether they are favorable or not) will be published in a peer-reviewed scientific journals.
Patient consent for publication.
Not applicable.
This study complies with the ethical research guidelines, already approved by the ethics committee by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee with the number 5.951.619 / Approval Number: 66250922200005078.
We acknowledge and appreciate the statistical support by José Eduardo Corrente/ Sigma Scientific consulting, Botucatu - SP.
Contributors Author Contributions: conceptualisation, ACFGA, RBC, TCFB, TNSD and FARJ; study design/methodology, ACFGA and RBC; writing original draft preparation, ACFGA and RBC; writing—review and editing, RLM, ALSF, MFSDR, ACFGA, TCFB, TNSD, FARJ, RLM, ALSF, MFSDR and RBC; supervision, RBC; and project administration, ACFGA and RBC.
Funding This study was supported by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) through Universidade Nove de Julho / UNINOVE / Brazil, Programa de Excelência Acadêmica PROEX, 88887.818181/2023-00.
Competing interests The authors declare no competing interests
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
This study aims to examine the clinical characteristics and surgical management of pediatric testicular epidermoid cysts, thereby contributing to the existing body of knowledge pertinent to the diagnosis and therapeutic intervention 你 s for this condition.
A retrospective analysis was conducted on the clinical records of 23 pediatric patients diagnosed with testicular epidermoid cysts, who were admitted to our institution between April 2013 and February 2024. Concurrently, a comprehensive review and analysis of pertinent literature were undertaken to augment the findings.
The mean age at which the onset of epidermoid cysts was observed was 6.0 years. All cases were singular and unilateral. B-ultrasound diagnosis categorized 6 cases as epidermoid cysts, 11 as teratomas, and 6 as indeterminate, yielding a diagnostic sensitivity of 26.1%. All patients underwent testicle-sparing mass resection, and nine patients underwent rapid intraoperative frozen section analysis, revealing eight cases of testicular epidermoid cysts and one teratoma, with a diagnostic sensitivity of 88.89%. Postoperative histopathological examination confirmed the diagnosis of testicular epidermoid cyst.
Pediatric testicular epidermoid cysts are an uncommon occurrence, primarily presenting as a painless scrotal mass, which can mimic the clinical features of malignant testicular tumors. Imaging modalities and histopathological assessment are pivotal in the diagnostic process for pediatric testicular epidermoid cysts. For cases where B-ultrasound is inconclusive, rapid intraoperative pathological examination should be considered.
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The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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The authors would like to thank the parents and children who enrolled in the study and the health professionals from the department of ultrasonography. Their outstanding support and contributions are gratefully appreciated.
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Authors and affiliations.
Department of Day Surgery, National Clinical Research Center for Child Health and Disorders, Ministry of Education, Key Laboratory of Child Development and Disorder, Children’s Hospital of Chongqing Medical University, Chongqing, China
Jie Tao, Fei Chen, Xia Chen & Junhong Liu
China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, China
Chongqing Key Laboratory of Structural Birth Defect and Reconstruction, Chongqing, China
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All authors have worked on the manuscript. Jie Tao wrote the manuscript under the supervision of Junhong Liu. Fei Chen and Xia Chen followed up the patient.
Correspondence to Junhong Liu .
Conflict of interest.
The authors declare that they have no conflict of interest.
This retrospective study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Tao, J., Chen, F., Chen, X. et al. Clinical analysis of 23 cases of epidermoid cyst of testis in children. Pediatr Surg Int 40 , 165 (2024). https://doi.org/10.1007/s00383-024-05750-9
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Accepted : 24 June 2024
Published : 02 July 2024
DOI : https://doi.org/10.1007/s00383-024-05750-9
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