Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial).

BACKGROUND: Recurrence rates after inguinal hernia repair have been reduced to a few per cent, since mesh repair has become standard of care. Lightweight meshes reduce post-operative pain and stiffness in open anterior repair, but for endoscopic repair, the discussion about this benefit is ongoing. This study was done to analyse the effects of lightweight mesh versus heavyweight mesh following endoscopic totally extraperitoneal (TEP) hernia repair. METHODS: In a single-centre double-blindly randomized clinical trial, 950 patients with unilateral primary inguinal hernia were randomized to undergo endoscopic TEP using either an Ultrapro(®) or a Prolene(®) mesh. Data were collected by validated questionnaires at day 1, day 7, after 6 weeks and after 3 months, and clinical assessment was performed after 3 months. The presence of groin pain after 3 months, defined as an NRS score >3, was evaluated as the primary outcome measure. Secondary outcomes were foreign body feeling and the impact of pain and foreign body feeling on daily activities. RESULTS: At 3-month follow-up, the incidence of pain (NRS 4-10) was 2 versus 0.9 % in the lightweight and heavyweight mesh group, respectively (p = 0.17). Pain interfered with daily activities in 1.7 % of the lightweight and 1.5 % of heavyweight group. In the lightweight group, 20 % of patients reported a foreign body feeling versus 18 % in the heavyweight group (p = 0.62). No differences between the groups were observed regarding time to return to work, interference with sports and sexual activities, testicular pain and ejaculatory pain. Severe preoperative pain (OR 2.01, 95 % CI 1.21-3.35, p = 0.01) was the only independent predictor of any post-operative pain after 3 months. CONCLUSION: Three months after TEP inguinal repair, there were no significant differences between lightweight and heavyweight mesh use regarding the incidence of pain, foreign body feeling or any other endpoint.

Is there an end of the "learning curve" of endoscopic totally extraperitoneal (TEP) hernia repair?

BACKGROUND: An important challenge of totally extraperitoneal (TEP) hernia repair is the learning curve. The European guidelines suggest that the learning curve ranges between 50 and 100 procedures, with the first 30-50 being critical. Others suggest that optimal outcomes are achieved after 200 or more TEP procedures. METHODS: All TEP repairs performed between 2005 and 2009 were included in this study. The effect of (surgeon) expertise on perioperative complications, conversion to open anterior repair, and operative time was assessed to evaluate the extent of the learning curve of TEP repair. RESULTS: Intraoperative complications occurred in <1 % of the 3,432 patients and postoperative complications were observed in 243 (7 %) patients. With a median follow-up of 2 years after TEP, 19 patients (0.55 %) had a recurrence. During the study period, at the end of which all four surgeons had treated 900-1,000 patients, intraoperative complications and recurrences did not decline. On the other hand, the median operative time decreased from 30 to 20 min (p < 0.001). The conversion rate (1.6-0.2 %, p = 0.018) and postoperative complication rate (11.6-4.2 %, p < 0.001) also declined. The decline was observed for all four surgeons, irrespective of their initial expertise with TEP. The largest decrease in the conversion rate was seen after at least 250 TEP procedures; the postoperative complication rate and operative time showed a linear and significant decline throughout the study period. A more or less "steady state" was observed after approximately 450 procedures per surgeon. CONCLUSIONS: Even after more than 400 individually performed TEP procedures, there is progress in reducing the conversion rate, the incidence of short-term postoperative complications, and operative time, indicating a rather long learning curve.

Effects of the introduction of the WHO "Surgical Safety Checklist" on in-hospital mortality: a cohort study.

OBJECTIVE: To evaluate the effect of implementation of the WHO's Surgical Safety Checklist on mortality and to determine to what extent the potential effect was related to checklist compliance. BACKGROUND: Marked reductions in postoperative complications after implementation of a surgical checklist have been reported. As compliance to the checklists was reported to be incomplete, it remains unclear whether the benefits obtained were through actual completion of a checklist or from an increase in overall awareness of patient safety issues. METHODS: This retrospective cohort study included 25,513 adult patients undergoing non-day case surgery in a tertiary university hospital. Hospital administrative data and electronic patient records were used to obtain data. In-hospital mortality within 30 days after surgery was the main outcome and effect estimates were adjusted for patient characteristics, surgical specialty and comorbidity. RESULTS: After checklist implementation, crude mortality decreased from 3.13% to 2.85% (P = 0.19). After adjustment for baseline differences, mortality was significantly decreased after checklist implementation (odds ratio [OR] 0.85; 95% CI, 0.73-0.98). This effect was strongly related to checklist compliance: the OR for the association between full checklist completion and outcome was 0.44 (95% CI, 0.28-0.70), compared to 1.09 (95% CI, 0.78-1.52) and 1.16 (95% CI, 0.86-1.56) for partial or noncompliance, respectively. CONCLUSIONS: Implementation of the WHO Surgical Checklist reduced in-hospital 30-day mortality. Although the impact on outcome was smaller than previously reported, the effect depended crucially upon checklist compliance.

Management strategies and outcome of blunt traumatic abdominal wall defects: a single centre experience.

INTRODUCTION: Traumatic abdominal wall defects (TAWDs) following blunt trauma are uncommon injuries with an incidence reported less than 1%. Improved diagnostics and subsequent early detection of otherwise rare injuries raise more questions concerning their treatment. There is lack of consensus on treatment and timing of TAWD. The aim of this study was to analyse the management strategy and outcomes of these injuries in our level I trauma centre. METHODS: All trauma patients who presented with a TAWD at our trauma centre between 2007 and 2016 were retrospectively reviewed. Blunt abdominal wall injuries were classified, patient characteristics, concomitant injuries and treatment characteristics were recorded. In addition, telephone surveys were conducted to assess patient reported quality of life. RESULTS: In a period of nearly ten years 21 patients with a TAWD were treated in our hospital, approximately 0.17% of all admitted trauma patients. Seventeen patients were classified as polytrauma patient. Seventeen patients underwent surgical repair in whom 5 recurrences occurred. All of the recurrences were in patients treated without mesh repair (p = 0.03). The quality of life in terms of EQ-VAS was similar for patients treated with and without mesh repair and reasonable when compared to the reference population. Overall quality of life was lower compared to the reference population, mainly due to limitations in daily activities, mobility and pain. CONCLUSION: Using mesh in the treatment of TAWD, in our hands, showed significantly less recurrences compared to primary closure. We therefore recommend the use of mesh in the repair of TAWDs, both in the acute as well as in the delayed setting when feasible.

An 11-year analysis of reoperated groins after endoscopic totally extraperitoneal (TEP) inguinal hernia repair in a high volume hernia center.

BACKGROUND: Developments in inguinal hernia surgery have substantially lowered recurrence rates, yet recurrences remain an important outcome parameter of inguinal hernia repair. The aim of this study was to analyze the characteristics of all reoperated groins after endoscopic totally extraperitoneal (TEP) inguinal hernia repair in a high-volume hernia clinic in the Netherlands. METHODS: All groins with recurrence-like symptoms reoperated after previous TEP inguinal hernia repair between January 2006 and December 2016 were analyzed. Patient characteristics, imaging findings, primary hernia type, time to recurrence and recurrence type were assessed. RESULTS: A total of 137 groins were reoperated in 130 patients. The median age at the TEP procedure was 55 years [interquartile range (IQR) 45-64 years]. Fifty-seven groins were initially part of a bilateral procedure (42%). Median time until recurrence was 9 months (IQR 4-26 months). Reoperation findings were a hernia recurrence in 76%, an isolated lipoma in 18%, and no recurrence or lipoma in 6%. The majority of hernias recurred at their initial site (70%), of which the greatest part involved direct hernias. Isolated lipomas were more frequently seen after indirect hernia repair. CONCLUSIONS: Inguinal hernia recurrences were still observed in this high-volume hernia clinic. Recurrences were most frequently seen at their initial hernia site, the majority involving direct hernias. Isolated lipomas presenting as a pseudorecurrence were most frequently seen after correction of indirect hernias. In accordance with the current guidelines, reducing recurrence rates can be achieved by mesh fixation in bilateral, large and direct defects and by thoroughly reducing lipomas.

Accreditation and certification requirements for hernia centers and surgeons: the ACCESS project.

INTRODUCTION: There is a need for hernia centers and specialist hernia surgeons because of the increasing complexity of hernia surgery procedures due to new techniques, more difficult cases and a tailored approach with an increasing public awareness demanding optimal treatment results. Therefore, the requirements for accredited/certified hernia centers and specialist hernia surgeons should be formulated by the international and national hernia societies, while taking account of the respective health care systems. METHODS: The European Hernia Society (EHS) has appointed a working group composed of 18 hernia experts from all regions of Europe (ACCESS Group-Hernia Accreditation and Certification of Centers and Surgeons-Working Group) to formulate scientifically based requirements for hernia centers and specialist hernia surgeons while taking into consideration different health care systems. A consensus was reached on the key questions by means of a meeting, a telephone conference and the exchange of contributions. The requirements formulated below were deemed implementable by all participating hernia experts in their respective countries. RESULTS: The ACCESS Group suggests for an adequately equipped hernia center the following requirements: (a) to be accredited/certified by a national or international hernia society, (b) to perform a higher case volume in all types of hernia surgery compared to an average general surgery department in their country, (c) to be staffed by experienced hernia surgeons who are beyond the learning curve for all types of hernia surgery recommended in the guidelines and are responsible for education and training of hernia surgery in their department, (d) to treat hernia patients according to the current guidelines and scientific recommendations, (e) to document each case prospectively in a registry or quality assurance database (f) to perform follow-up for comparison of their own results with benchmark data for continuous improvement of their treatment results and ensuring contribution to research in hernia treatment. To become a specialist hernia surgeon, the ACCESS Group suggests a general surgeon to master the learning curve of all open and laparo-endoscopic hernia procedures recommended in the guidelines, perform a high caseload and additionally to implement and fulfill the other requirements for a hernia center. CONCLUSION: Based on the above requirements formulated by the European Hernia Society for accredited/certified hernia centers and hernia specialist surgeons, the national and international hernia societies can now develop their own programs, while taking account of their specific health care systems.

The reality of general surgery training and increased complexity of abdominal wall hernia surgery.

INTRODUCTION: The Accreditation and Certification of Hernia Centers and Surgeons (ACCESS) Group of the European Hernia Society (EHS) recognizes that there is a growing need to train specialist abdominal wall surgeons. The most important and relevant argument for this proposal and statement is the growing acceptance of the increasing complexity of abdominal wall surgery due to newer techniques, more challenging cases and the required 'tailored' approach to such surgery. There is now also an increasing public awareness with social media, whereby optimal treatment results are demanded by patients. However, to date the complexity of abdominal wall surgery has not been properly or adequately defined in the current literature. METHODS: A systematic search of the available literature was performed in May 2019 using Medline, PubMed, Scopus, Embase, Springer Link, and the Cochrane Library, with 75 publications identified as relevant. In addition, an analysis of data from the Herniamed Hernia Registry was performed. The percentage of patients with hernia- or patient-related characteristics which unfavorably impacted the outcome of inguinal and incisional hernia repair was also calculated. RESULTS: All present guidelines for abdominal wall surgery recommend the utilization of a 'tailored' approach. This relies on the prerequisite that any surgical technique used has already been mastered, as well as the recognized learning curves for each of the several techniques that can be used for both inguinal hernia (Lichtenstein, TEP, TAPP, Shouldice) and incisional hernia repairs (laparoscopic IPOM, open sublay, open IPOM, open onlay, open or endoscopic component separation technique). Other hernia- and patient-related characteristics that have recognized complexity include emergency surgery, obesity, recurrent hernias, bilateral inguinal hernias, groin hernia in women, scrotal hernias, large defects, high ASA scores, > 80 years of age, increased medical risk factors and previous lower abdominal surgery. The proportion of patients with at least one of these characteristics in the Herniamed Hernia Registry in the case of both inguinal and incisional hernia is noted to be relatively high at around 70%. In general surgery training approximately 50-100 hernia repairs on average are performed by each trainee, with around only 25 laparo-endoscopic procedures. CONCLUSION: A tailored approach is now employed and seen more so in hernia surgery and this fact is referred to and highlighted in the contemporaneous hernia guidelines published to date. In addition, with the increasing complexity of abdominal wall surgery, the number of procedures actually performed by trainees is no longer considered adequate to overcome any recognized learning curve. Therefore, to supplement general surgery training young surgeons should be offered a clinical fellowship to obtain an additional qualification as an abdominal wall surgeon and thus improve their clinical and operative experience under supervision in this field. Practicing general surgeons with a special interest in hernia surgery can undertake intensive further training in this area by participating in clinical work shadowing in hernia centers, workshops and congresses.

[Therapy-resistant gastro-oesophageal reflux disease: endoluminal treatment not yet sufficiently compared with the gold standard, the laparoscopic Nissen fundoplication]. / Therapieresistente gastro-oesofageale refluxziekte: endoluminale behandeling nog onvoldoende vergeleken met de gouden standaard, laparoscopische fundoplicatie volgens Nissen.

Gastro-oesophageal reflux disease (GORD) is treated primarily with proton pump inhibitors. More invasive treatment is only indicated for patients with persistent symptoms or when complications occur. Anti-reflux surgery is successful in 85-90% of patients in terms of symptom control, healing of oesophagitis and normalization of oesophageal stomach-acid exposure. Laparoscopic Nissen fundoplication is the standard surgical procedure and favourable results persist for at least 5 years. Endoluminal treatment for GORD is a new development for which no long-term results are known and which can probably only be implemented in some of the patients with disease refractory to therapy. The effect of the new endoluminal treatments will have to be evaluated in randomised trials and to be compared with the medical gold standard of treatment, proton pump inhibitors, and with the surgical gold standard, laparoscopic Nissen fundoplication.

The European hernia society groin hernia classification: simple and easy to remember.

After reviewing the available classifications for groin hernias, the European Hernia Society (EHS) proposes an easy and simple classification based on the Aachen classification. The EHS will promote the general and systematic use of this classification for intraoperative description of the type of hernia and to increase the comparison of results in the literature.

[Emergency laparotomy in a trauma patient]. / De spoedlaparotomie bij een traumapatiënt.

- Emergency laparotomy in trauma patients can be part of the resuscitation process, is based on damage control principles and is therefore fundamentally different from elective laparotomy, for example in case of malignancies. - Indications for emergency laparotomy after trauma are based on haemodynamic instability of the patient and the procedure is focused on restoring the patient's physiological condition.- Haemodynamic and biochemical parameters are used to determine the rest of the strategy. In order to optimize the procedure, the entire treatment team should be practiced in this.- Fewer and fewer surgeons are carrying out general laparotomies and even fewer are carrying out emergency laparotomies after trauma.- Knowledge and skills about emergency laparotomy after trauma are at risk of disappearing because of this, not only for surgeons but also for other team members.- Increased centralisation, team training, more cooperation and consultation for specific indications may all contribute to expertise preservation.

Recurrent paraesophageal hernia due to diaphragm rupture: a case report.

A 58-year-old male patient was operated for complaints of dysphagia, anemia and retrosternal discomfort due to a type II hiatal hernia. A complete hernia sac excision and posterior crural repair was performed laparoscopically with support of the da Vincitrade mark robotic system. An antireflux procedure was not performed because of the absence of gastroesophageal reflux disease. Nine months after surgery the patient presented with recurrent complaints of dysphagia and retrosternal pain. Barium esophagram series revealed a recurrent paraesophageal hernia which was confirmed on esophagogastroscopy. A robot-assisted re-laparoscopy was performed. Left to the still intact hiatoplasty of the original operation a tear in the diaphragm, through which part of the stomach covered with peritoneum had herniated, was encountered. The hernia sac was excised, the diaphragmatic defect closed and reinforced with an expanded polytetrafluoroethylene strip of 5 x 8 cm. After surgery the patient recovered quickly, oral intake was resumed on the first postoperative day and the hospital stay was 3 days. The use of prosthetic mesh to reinforce the hiatoplasty and the addition of an antireflux procedure after hiatal hernia repair are ongoing controversial aspects of hiatal hernia repair. Reports on laparoscopic redo surgery for recurrent diaphragmatic hernia are limited and will be addressed in this case report, in perspective of the aforementioned controversial components.

Chronic pain after TEP inguinal hernia repair, does MRI reveal a cause?

PURPOSE: Persistent pain is a known side effect after TEP inguinal repair disabling 2-5% of patients. A standardized diagnostic work-up so far is not available. MRI is a diagnostic tool in the work-up of inguinal hernias. In the present study the yield of MRI in evaluating chronic pain after TEP hernia repair is addressed. METHODS: In our database patients receiving an MRI scan for groin pain lasting more than 3 months after TEP inguinal hernia repair were identified. A checklist with potential pathologic findings was filled out for each groin by two blinded observers. Findings in painful, pain-free and unoperated groins were compared and statistical analysis done based upon their relative incidences. Cohen's kappa coefficients were calculated to determine interobserver agreement. RESULTS: Imaging studies of 53 patients revealed information regarding 106 groins. Fifty-five groins were painful after the initial operation, 12 were pain-free postoperatively and 39 groins were not operated. None of the predefined disorders was observed statistically more often in the patients with painful groins. Only fibrosis appeared more prevalent in patients with chronic pain (P = 0.11). Interobserver agreement was excellent for identifying the mesh (κ = 0.88) and observing bulging or a hernia (κ = 0.74) and was substantial for detecting fibrosis (κ = 0.63). In 40% of the patients, MRI showed a correct mesh position and observed nothing else than minor fibrosis. A wait and see policy resolved complaints in the majority of the patients. In 15 % of the patients, MRI revealed treatable findings explanatory for persisting groin pain. CONCLUSION: For patients with post-TEP hernia groin pain, MRI is useful to confirm a correct flat mesh position and to identify possible not operation-related causes of groin pain. It is of little help to identify a specific cause of groin repair-related pain.

Inguinal hernia surgery in The Netherlands: a baseline study before the introduction of the Dutch Guidelines.

BACKGROUND: In 2003 the Dutch Guidelines for treatment of inguinal hernia (IH) were published. For treatment of IH in adults, the evidence-based guidelines recommend the use of a mesh repair technique. In order to be able to evaluate the effects of these guidelines, a baseline analysis of inguinal hernia surgery before the introduction of these guidelines had to be performed. The second analysis will be performed two years (January-March 2005) after the publication of the Guidelines. OBJECTIVE: To make an inventory of IH surgery in the Netherlands, before the introduction of guidelines for IH treatment, to serve as a baseline for future evaluation of the impact of the implementation of these guidelines. METHODS: A retrospective descriptive study was performed in 2003 using patient and operation charts including IH repairs performed in The Netherlands over a three-month period (January-March 2001). RESULTS: 97/133 (73%) hospitals cooperated with the study, generating data from a total of 4386 IH in 3979 patients (3284 adults, 695 children). Mesh techniques were used in 2839 (78%) adult inguinal hernias while 800 (22%) patients were treated with non-mesh techniques. 484 (14.7%) adult patients were operated on during the study period for a recurrent hernia from previous years. Early recurrence (<1 year) occurred in 2.2% of all patients. Wound infection was documented in 0.8% of all IH. The mortality rate was 0.1%. 1257 of the 3284 (38.3%) adults, and 566 of the 695 children (81.4%), were operated on in ambulatory care. CONCLUSIONS: In the episode prior to implementation of the Dutch evidence-based Guidelines for treatment of inguinal hernia, 2839 (78%) adult patients were treated with mesh repair and 484 (13.3%) patients were treated for a recurrent hernia.

An algorithm for assessment and treatment of postherniorrhaphy pain.

BACKGROUND: Inguinal pain after groin hernia repair is a challenging issue. About 50 % of postherniorrhaphy pain allegedly is neuropathic, treatment of which is cumbersome given the limited efficacy of current therapeutic modalities. Possibly a clear protocol assessing the type of pain and treating it accordingly could improve its treatment. METHODS: A prospective study was done to evaluate an algorithm in patients with chronic postherniorrhaphy groin pain, aiming to select those with neuropathic pain and to treat appropriately. Treatment consisted of ultrasound-guided nerve blocks as an initial treatment for neuropathic pain. If long-term pain reduction proved inadequate, peripheral nerve stimulation was offered. RESULT: After our diagnostic workup consisting of anamnesis, physical examination and imaging, 68 patients out of 105 were diagnosed as having non-neuropathic pain. These patients were referred to the most appropriate consultant, treated accordingly or sometimes pain appeared to be self-limiting. Thirty-seven (35 %) patients were diagnosed as having neuropathic pain with a median NRS of 7 (range 4-9) and were referred for further treatment to our pain clinic. The majority (21 of 28 patients) suffered ileo-inguinal nerve involvement. After ultrasound-guided nerve blocks, a permanent reduction in pain was achieved in 18 patients (62 %) with a median post-treatment NRS of 1 (range 0-3). In six patients to which an additional peripheral nerve stimulator (PNS) was offered, pain reduction to a level of mild complaints with a median NRS of 2 (range 1-8) was observed. In total, 24 of the 28 patients (83 %) diagnosed with neuropathic postherniorrhaphy pain achieved significant pain reduction after algorithm-based treatment. CONCLUSIONS: In the present study, we implemented a diagnostic workup for patients with postherniorrhaphy inguinal pain to select those with neuropathic pain. Eighty-three percent of the patients with neuropathic groin pain obtained significant improvement of their pain scores after our protocolled treatment. The effect was achieved by nerve infiltrations and in some cases by an implanted PNS when the former was unsuccessful.

Pain after totally extraperitoneal (TEP) hernia repair might fade out within a year.

BACKGROUND: The incidence of chronic pain after endoscopic hernia repair varies between 1 and 16 %. Studies regarding the course of pain in time after the operation are scarce. METHODS: 473 male patients ≥18 years of age, scheduled for totally extraperitoneal (TEP) hernia repair (Prolene® mesh) between March 2010 and August 2012 were requested to record pain symptoms preoperative, and 1 day, 1 week, 6 weeks, 3 months and 1 year postoperatively and visit the outpatient department 3 months and 1 year postoperatively for a standardized interview and physical examination. RESULTS: Preoperatively, 25 % (n = 114) of the patients had moderate-to-severe pain (NRS 4-10). Six weeks postoperatively, 3 % (n = 12) of the patients still experienced moderate-to-severe pain. Three months after TEP, only 3 patients (0.6 %) had moderate-to-severe pain, while 83 patients (18 %) experienced mild pain. One year after TEP, 39 patients experienced mild pain (8 %) and 3 patients moderate pain (0.7 %), no patients experienced severe pain after 1 year. Patients with moderate-to-severe pain preoperatively had a higher risk of pain persisting until 3 months and 1 year postoperatively (p = 0.03). In most patients who had pain 3 months postoperatively and were pain-free 1 year after TEP, pain 'faded out' at 4-6 months postoperatively. Two patients had a not-painful recurrent hernia, diagnosed 2 and 5 months after TEP repair. CONCLUSION: Moderate-to-severe pain after TEP hernia repair is self-limiting, with less than 1 % of the patients reporting moderate pain 1 year postoperatively.

Anatomical considerations for surgery of the anterolateral abdominal wall.

Closure of large incisional hernias with the Components Separation Method (CSM) could be explained by medial-caudal rotation of the internal and transverse oblique muscles around their centres of origin. In eight human cadavers, the CSM was performed, and translation of the rectus abdominis muscle was measured. Mean unilateral translation of the rectus abdominis in the lateral-medial direction measured 2.2, 3.7, and 3.5 cm. This was 2.7, 4.5, and 4.0 cm after release of the posterior rectus sheath. Mean translation in a caudal direction was 0.5 cm, but seven cadavers showed a mean translation of 1 cm of the uppermost measuring point in a cranial direction. The hypothesis that rotation of separate tissue layers of the abdominal wall largely accounts for the translation effect of the CSM must be rejected. Release of the external oblique muscle produces more benefit to abdominal wall closure than release of the posterior rectus sheath.

[Results of randomised clinical trial: not necessarily positively received]. / Gerandomiseerd klinisch onderzoek: niet per se positieve ontvangst.

The acceptance for publication and the implementation of the results of a randomised clinical trial are determined not only by the quality of the study, but also by its timing and the prevailing opinion prior to the study. In a randomised study, comparing laparoscopic and open fundoplication in patients with gastro-oesophageal reflux, interim analysis showed statistically significantly more complications related to laparoscopic intervention. Publication of the study led to an avalanche of criticism focusing mainly on the inexperience of the surgeons. The cost-effectiveness analysis, showing that open fundoplication had fewer complications and was cheaper, was repeatedly rejected by established journals mainly because of criticism of surgical aspects of the study. In the meanwhile a study on a second group of 100 patients was initiated. They underwent laparoscopic fundoplication conducted by two experienced surgeons. The results were statistically significantly better than in the laparoscopic arm of the initial randomised trial. The learning curve proved to be longer than had previously been thought.

Selecting patients during the "learning curve" of endoscopic Totally Extraperitoneal (TEP) hernia repair.

BACKGROUND: Totally Extraperitoneal (TEP) hernia surgery is associated with little postoperative pain and a fast recovery, but is a technically demanding operative procedure. Apart from the surgeon's expertise, patient characteristics and hernia-related variations may also affect the operative time and outcome. METHODS: Patient-related factors predictive of perioperative complications, conversion to open anterior repair, and operative time were studied in a cohort of consecutive patients undergoing TEP hernia repair from 2005 to 2009. RESULTS: A total of 3,432 patients underwent TEP. The mean operative time was 26 min (SD ± 10.9), TEP was converted into an open anterior approach in 26 patients (0.8 %), and perioperative complications were observed in 55 (1.6 %) patients. Multivariable regression analysis showed that a history of abdominal surgery (OR 1.76, 95 per cent confidence interval 1.01-3.06; p = 0.05), and the presence of a scrotal (OR 5.31, 1.20-23.43; p = 0.03) or bilateral hernia (OR 2.25, 1.25-4.06; p = 0.01) were independent predictive factors of perioperative complications. Female gender (OR 5.30. 1.52-18.45; p = 0.01), a history of abdominal surgery (OR 3.96, 1.72- 9.12; p = 0.001), and the presence of a scrotal hernia (OR 34.84, 10.42-116.51, p < 0.001) were predictive factors for conversion. A BMI ≥ 25 (effect size (ES) 1.78, 95 % confidence interval 1.09-2.47; p < 0.001) and the presence of a scrotal (ES 5.81, 1.93-9.68; p = 0.003), indirect (ES 2.78, 2.05- 3.50, p < 0.001) or bilateral hernia (ES 10.19, 9.20-11.08; p < 0.001) were associated with a longer operative time. CONCLUSION: Certain patient characteristics are, even in experienced TEP surgeons, associated with an increased risk of conversion and complications and a longer operative time. For the surgeon gaining experience with TEP, it seems advisable to select relatively young and slender male patients with a unilateral (non-scrotal) hernia and no previous abdominal surgery to enhance patient safety and 'surgeon comfort'.

Recommendations for reporting outcome results in abdominal wall repair: results of a Consensus meeting in Palermo, Italy, 28-30 June 2012.

BACKGROUND: The literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology. MATERIALS AND METHODS: The EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction. RESULTS: A list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of "time-to-event analysis" to report data on "freedom-of-recurrence" rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods. CONCLUSION: A set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.