Sex, Gender, and Pain: A Review of Recent Clinical and Experimental Findings

Objectives: To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals. Design: Survey of all reports of randomised controlled trials published in 1997 in the BMJ, Lancet, JAMA , and New England Journal of Medicine . Main outcome measures: Methods of dealing with deviations from random allocation and missing data. Results: 119 (48%) of the reports mentioned intention to treat analysis. Of these, 12 excluded any patients who did not start the allocated intervention and three did not analyse all randomised subjects as allocated. Five reports explicitly stated that there were no deviations from random allocation. The remaining 99 reports seemed to analyse according to random allocation, but only 34 of these explicitly stated this. 89 (75%) trials had some missing data on the primary outcome variable. The methods used to deal with this were generally inadequate, potentially leading to a biased treatment effect. 29 (24%) trials had more than 10% of responses missing for the primary outcome, the methodsof handling the missing responses were similar in this subset. Conclusions: The intention to treat approach is often inadequately described and inadequately applied. Authors should explicitly describe the handling of deviations from randomised allocation and missing responses and discuss the potential effect of any missing response. Readers should critically assess the validity of reported intention to treat analyses. Key messages Intention to treat gives a pragmatic estimate of the benefit of a change in treatment policy rather than of potential benefit in patients who receive treatment exactly as planned Full application of intention to treat is possible only when complete outcome data are available for all randomised subjects About half of all published reports of randomised controlled trials stated that intention to treat was used, but handling of deviations from randomised allocation varied widely Many trials had some missing data on the primary outcome variable, and methods used to deal with this were generally inadequate, potentially leading to bias Intention to treat analyses are often inadequately described and inadequately applied

https://www.bmj.com/content/bmj/319/7211/670.full.pdf

What is meant by intention to treat analysis? Survey of published randomised controlled trials

ONE potential adverse outcome from surgery is chronic pain. Analysis of predictive and pathologic factors is important to develop rational strategies to prevent this problem. Additionally, the natural history of patients with and without persistent pain after surgery provides an opportunity to improve the understanding of the physiology and psychology of chronic pain. Ideally, studies of chronic postoperative pain should include (1) sufficient preoperative data (assessment of pain, physiologic and psychologic risk factors for chronic pain); (2) detailed descriptions of the operative approaches used (location and length of incisions, handling of nerves and muscles); (3) the intensity and character of acute postoperative pain and its management; and (4) follow-up at intervals to 1 yr or more. In addition, there would be information about postoperative interventions that may influence pain, such as radiation therapy or chemotherapy. At long-term follow-up visits, patient function, physical signs, and symptoms would be evaluated using a standardized algorithm, including quantitative and descriptive pain assessments. We found no studies that contain all of these data. For this review, we specifically sought population data that reflect the incidence of chronic postoperative pain or predictors (medical, physiologic, and psychologic) of chronic pain. We selected five groups of surgeries (limb amputations, breast surgery, gallbladder surgery, lung surgery, and inguinal hernia surgery). These surgeries were selected because the incidence of pain is known to be high, thus improving the probability of detecting predictive factors. They also represent a range of major surgical procedures.

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Chronic pain as an outcome of surgery. A review of predictive factors.

The European Hernia Society (EHS) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS. They are evidence-based and, when necessary, a consensus was reached among all members. The Guidelines have been reviewed by a Steering Committee. Before finalisation, feedback from different national hernia societies was obtained. The Appraisal of Guidelines for REsearch and Evaluation (AGREE) instrument was used by the Cochrane Association to validate the Guidelines. The Guidelines can be used to adjust local protocols, for training purposes and quality control. They will be revised in 2012 in order to keep them updated. In between revisions, it is the intention of the Working Group to provide every year, during the EHS annual congress, a short update of new high-level evidence (randomised controlled trials [RCTs] and meta-analyses). Developing guidelines leads to questions that remain to be answered by specific research. Therefore, we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment. In addition, a short summary, specifically for the general practitioner, is given. In order to increase the practical use of the Guidelines by consultants and residents, more details on the most important surgical techniques, local infiltration anaesthesia and a patient information sheet is provided. The most important challenge now will be the implementation of the Guidelines in daily surgical practice. This remains an important task for the EHS. The establishment of an EHS school for teaching inguinal hernia repair surgical techniques, including tips and tricks from experts to overcome the learning curve (especially in endoscopic repair), will be the next step. Working together on this project was a great learning experience, and it was worthwhile and fun. Cultural differences between members were easily overcome by educating each other, respecting different views and always coming back to the principles of evidence-based medicine. The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project.

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European Hernia Society guidelines on the treatment of inguinal hernia in adult patients

Worldwide, more than 20 million patients undergo groin hernia repair annually. The many different approaches, treatment indications and a significant array of techniques for groin hernia repair warrant guidelines to standardize care, minimize complications, and improve results. The main goal of these guidelines is to improve patient outcomes, specifically to decrease recurrence rates and reduce chronic pain, the most frequent problems following groin hernia repair. They have been endorsed by all five continental hernia societies, the International Endo Hernia Society and the European Association for Endoscopic Surgery. 
An expert group of international surgeons (the HerniaSurge Group) and one anesthesiologist pain expert was formed. The group consisted of members from all continents with specific experience in hernia-related research. Care was taken to include surgeons who perform different types of repair and had preferably performed research on groin hernia surgery. During the Group's first meeting, evidence-based medicine (EBM) training occurred and 166 key questions (KQ) were formulated. EBM rules were followed in complete literature searches (including a complete search by The Dutch Cochrane database) to January 1, 2015 and to July 1, 2015 for level 1 publications. The articles were scored by teams of two or three according to Oxford, SIGN and Grade methodologies. During five 2-day meetings, results were discussed with the working group members leading to 136 statements and 88 recommendations. Recommendations were graded as "strong" (recommendations) or "weak" (suggestions) and by consensus in some cases upgraded. In the Results and summary section below, the term "should" refers to a recommendation. The AGREE II instrument was used to validate the guidelines. An external review was performed by three international experts. They recommended the guidelines with high scores. 
The risk factors for inguinal hernia (IH) include: family history, previous contra-lateral hernia, male gender, age, abnormal collagen metabolism, prostatectomy, and low body mass index. Peri-operative risk factors for recurrence include poor surgical techniques, low surgical volumes, surgical inexperience and local anesthesia. These should be considered when treating IH patients. IH diagnosis can be confirmed by physical examination alone in the vast majority of patients with appropriate signs and symptoms. Rarely, ultrasound is necessary. Less commonly still, a dynamic MRI or CT scan or herniography may be needed. The EHS classification system is suggested to stratify IH patients for tailored treatment, research and audit. Symptomatic groin hernias should be treated surgically. Asymptomatic or minimally symptomatic male IH patients may be managed with "watchful waiting" since their risk of hernia-related emergencies is low. The majority of these individuals will eventually require surgery; therefore, surgical risks and the watchful waiting strategy should be discussed with patients. Surgical treatment should be tailored to the surgeon's expertise, patient- and hernia-related characteristics and local/national resources. Furthermore, patient health-related, life style and social factors should all influence the shared decision-making process leading up to hernia management. Mesh repair is recommended as first choice, either by an open procedure or a laparo-endoscopic repair technique. One standard repair technique for all groin hernias does not exist. It is recommended that surgeons/surgical services provide both anterior and posterior approach options. Lichtenstein and laparo-endoscopic repair are best evaluated. Many other techniques need further evaluation. Provided that resources and expertise are available, laparo-endoscopic techniques have faster recovery times, lower chronic pain risk and are cost effective. There is discussion concerning laparo-endoscopic management of potential bilateral hernias (occult hernia issue). After patient consent, during TAPP, the contra-lateral side should be inspected. This is not suggested during unilateral TEP repair. After appropriate discussions with patients concerning results tissue repair (first choice is the Shouldice technique) can be offered. Day surgery is recommended for the majority of groin hernia repair provided aftercare is organized. Surgeons should be aware of the intrinsic characteristics of the meshes they use. Use of so-called low-weight mesh may have slight short-term benefits like reduced postoperative pain and shorter convalescence, but are not associated with better longer-term outcomes like recurrence and chronic pain. Mesh selection on weight alone is not recommended. The incidence of erosion seems higher with plug versus flat mesh. It is suggested not to use plug repair techniques. The use of other implants to replace the standard flat mesh in the Lichtenstein technique is currently not recommended. In almost all cases, mesh fixation in TEP is unnecessary. In both TEP and TAPP it is recommended to fix mesh in M3 hernias (large medial) to reduce recurrence risk. Antibiotic prophylaxis in average-risk patients in low-risk environments is not recommended in open surgery. In laparo-endoscopic repair it is never recommended. Local anesthesia in open repair has many advantages, and its use is recommended provided the surgeon is experienced in this technique. 
General anesthesia is suggested over regional in patients aged 65 and older as it might be associated with fewer complications like myocardial infarction, pneumonia and thromboembolism. Perioperative field blocks and/or subfascial/subcutaneous infiltrations are recommended in all cases of open repair. Patients are recommended to resume normal activities without restrictions as soon as they feel comfortable. Provided expertise is available, it is suggested that women with groin hernias undergo laparo-endoscopic repair in order to decrease the risk of chronic pain and avoid missing a femoral hernia. Watchful waiting is suggested in pregnant women as groin swelling most often consists of self-limited round ligament varicosities. Timely mesh repair by a laparo-endoscopic approach is suggested for femoral hernias provided expertise is available. All complications of groin hernia management are discussed in an extensive chapter on the topic. Overall, the incidence of clinically significant chronic pain is in the 10-12% range, decreasing over time. Debilitating chronic pain affecting normal daily activities or work ranges from 0.5 to 6%. Chronic postoperative inguinal pain (CPIP) is defined as bothersome moderate pain impacting daily activities lasting at least 3 months postoperatively and decreasing over time. CPIP risk factors include: young age, female gender, high preoperative pain, early high postoperative pain, recurrent hernia and open repair. For CPIP the focus should be on nerve recognition in open surgery and, in selected cases, prophylactic pragmatic nerve resection (planned resection is not suggested). It is suggested that CPIP management be performed by multi-disciplinary teams. It is also suggested that CPIP be managed by a combination of pharmacological and interventional measures and, if this is unsuccessful, followed by, in selected cases (triple) neurectomy and (in selected cases) mesh removal. For recurrent hernia after anterior repair, posterior repair is recommended. If recurrence occurs after a posterior repair, an anterior repair is recommended. After a failed anterior and posterior approach, management by a specialist hernia surgeon is recommended. Risk factors for hernia incarceration/strangulation include: female gender, femoral hernia and a history of hospitalization related to groin hernia. It is suggested that treatment of emergencies be tailored according to patient- and hernia-related factors, local expertise and resources. Learning curves vary between different techniques. Probably about 100 supervised laparo-endoscopic repairs are needed to achieve the same results as open mesh surgery like Lichtenstein. It is suggested that case load per surgeon is more important than center volume. It is recommended that minimum requirements be developed to certify individuals as expert hernia surgeon. The same is true for the designation "Hernia Center". From a cost-effectiveness perspective, day-case laparoscopic IH repair with minimal use of disposables is recommended. The development and implementation of national groin hernia registries in every country (or region, in the case of small country populations) is suggested. They should include patient follow-up data and account for local healthcare structures. A dissemination and implementation plan of the guidelines will be developed by global (HerniaSurge), regional (international societies) and local (national chapters) initiatives through internet websites, social media and smartphone apps. 
An overarching plan to improve access to safe IH surgery in low-resource settings (LRSs) is needed. It is suggested that this plan contains simple guidelines and a sustainability strategy, independent of international aid. It is suggested that in LRSs the focus be on performing high-volume Lichtenstein repair under local anesthesia using low-cost mesh. Three chapters discuss future research, guidelines for general practitioners and guidelines for patients. 
The HerniaSurge Group has developed these extensive and inclusive guidelines for the management of adult groin hernia patients. It is hoped that they will lead to better outcomes for groin hernia patients wherever they live. More knowledge, better training, national audit and specialization in groin hernia management will standardize care for these patients, lead to more effective and efficient healthcare and provide direction for future research.

/pdf/international-guidelines-for-groin-hernia-management-3otlldvdxc.pdf

International guidelines for groin hernia management

Background Inguinal hernias can be repaired by laparoscopic techniques, which have had better results than open surgery in several small studies. Methods We performed a randomized, multicenter trial in which 487 patients with inguinal hernias were treated by extraperitoneal laparoscopic repair and 507 patients were treated by conventional anterior repair. We recorded information about postoperative recovery and complications and examined the patients for recurrences one and six weeks, six months, and one and two years after surgery. Results Six patients in the open-surgery group but none in the laparoscopic-surgery group had wound abscesses (P = 0.03), and the patients in the laparoscopic-surgery group had a more rapid recovery (median time to the resumption of normal daily activity, 6 vs. 10 days; time to the return to work, 14 vs. 21 days; and time to the resumption of athletic activities, 24 vs. 36 days; P<0.001 for all comparisons). With a median follow-up of 607 days, 31 patients (6 percent) in the o...

https://www.nejm.org/doi/pdf/10.1056/NEJM199705293362201

Comparison of Conventional Anterior Surgery and Laparoscopic Surgery for Inguinal-Hernia Repair

Background Several laparoscopic techniques have been introduced to repair inguinal hernia, the newest and most promising being a totally extraperitoneal approach. Nevertheless, the surgeon may encounter several complications and technical difficulties associated with the transition from the conventional anterior operation. Methods In late 1993 and 1994, 120 patients were operated on for inguinal hernia using the totally extraperitoneal approach by four laparoscopic surgeons inexperienced in this new technique in a secondary referral setting. Their learning curve was assessed through operation time, perioperative and postoperative complications, and technical difficulties. Results Median operative time decreased significantly (P = 0.0003) when going through the learning curve. During the initial part of the learning curve, conversion to another technique was necessary in 10 (8%) cases, and in 6 of these cases, conversion was needed for a peritoneal tear (relative risk for conversion if peritoneal tear was present: 4.0; 95% confidence interval 1.2 to 13.1, P = 0.025). The median operative time for Nyhus type Illb and IVb hernias was significantly longer than for other types (70 versus 55 minutes, P = 0.003). Median postoperative stay was 2 days (range 0 to 7). There were 10 recurrences within 6 months due to technical or judgement errors. Conclusions For surgeons, the learning curve for totally extraperitoneal laparoscopic hernia repair can be overcome; however, the presence of an experienced surgeon during the procedure is vital, as this may prevent unnecessary recurrences.

The learning curve for totally extraperitoneal laparoscopic inguinal hernia repair

Inguinal hernia repair is one of the most common operations performed, and both open and laparoscopic techniques are used. Several randomized trials have compared both techniques but have not elucidated the place of laparoscopic inguinal hernia repair. 1 Patients with inguinal hernia treated with laparoscopic repair have less postoperative pain and fewer wound infections and return to normal activity and work sooner. However, open repair is less expensive and easier to learn. 2–5 The most important outcome after inguinal hernia repair, however, is recurrence rate. Most randomized trials have been too small to detect differences in recurrence rate, and follow-up is still short. Recurrences can be detected reliably by physical examination, but many patients are generally lost to follow-up. Reliable, complete long-term follow-up has not been reported yet.

Our large, multicenter randomized trial 3 found fewer early complications and chronic inguinal pain and fewer short-term recurrences among patients who underwent laparoscopic repair. We now report the long-term complications and recurrence rate to assess the role of laparoscopic inguinal hernia repair in our patients.

Recurrences After Conventional Anterior and Laparoscopic Inguinal Hernia Repair: A Randomized Comparison

Objective To determine the cost-effectiveness of laparoscopic inguinal hernia repair. Summary Background Data Laparoscopic inguinal hernia repair seems superior to open techniques with respect to short-term results. An issue yet to be studied in depth remains the cost-effectiveness of the procedure. As part of a multicenter randomized study in which >1000 patients were included, a cost-effectiveness analysis from a societal point of view was performed. Methods After informed consent, all resource costs, both in and outside the hospital, for patients between August 1994 and July 1995 were recorded prospectively. Actual costs were calculated in a standardized fashion according to international guidelines. The main measures used for the evaluation of inguinal hernia repair were the number of averted recurrences and quality of life measured with the Short Form 36 questionnaire. Results Resource costs were recorded for 273 patients, 139 in the open and 134 in the laparoscopic group. Both groups were comparable at baseline. Average total hospital costs were Dfl 1384.91 (standard deviation: Dfl 440. 15) for the open repair group and Dfl 2417.24 (standard deviation: Dfl 577. 10) for laparoscopic repair, including a disposable kit of Dfl 676. Societal costs, including costs for days of sick leave, were lower for the laparoscopic repair and offset the hospital costs by Dfl 780.83 (75.6%), leaving the laparoscopic repair Dfl 251.50 more expensive (Dfl 4665 versus Dfl 4916.50). At present, the recurrence rate is 2.6% lower after laparoscopic repair. Thus, 38 laparoscopic repairs, costing an additional Dfl 9,557, prevent the occurrence of one recurrent hernia. Quality of life was better after laparoscopic repair. Conclusion A better quality of life in the recovery period and the possibility of replacing parts of the disposable kit with reusable instruments may result in the laparoscopic repair becoming dominantly better-that is, less expensive and more effective from a societal perspective.

M. S. L. Liem

Papers

Comparison of Conventional Anterior Surgery and Laparoscopic Surgery for Inguinal-Hernia Repair

The learning curve for totally extraperitoneal laparoscopic inguinal hernia repair

Recurrences After Conventional Anterior and Laparoscopic Inguinal Hernia Repair: A Randomized Comparison

Cost-effectiveness of extraperitoneal laparoscopic inguinal hernia repair: a randomized comparison with conventional herniorrhaphy. Coala trial group.

Comparison of Conventional Anterior Surgery and Laparoscopic Surgery for Inguinal Hernia Repair