Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial.

PURPOSE: Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure in preventing a parastomal hernia, we performed a multicentre randomized controlled trial in 11 large teaching hospitals and three university centres in The Netherlands. METHODS: Augmentation of the abdominal wall with a retromuscular light-weight polypropylene mesh (Parietene Light™, Covidien) around the trephine was compared with traditional colostomy formation. Patients undergoing elective open formation of a permanent end-colostomy were eligible. 150 patients were randomized between 2010 and 2012. Primary endpoint of the PREVENT trial is the incidence of parastomal hernia. Secondary endpoints are morbidity, pain, quality of life, mortality and cost-effectiveness. This article focussed on the early results of the PREVENT trial and, therefore, operation time, postoperative morbidity, pain, and quality of life were measured. RESULTS: Outcomes represent results after 3 months of follow-up. A total of 150 patients were randomized. Mean operation time of the mesh group (N = 72) was significantly longer than in the control group (N = 78) (182.6 vs. 156.8 min; P = 0.018). Four (2.7 %) peristomal infections occurred of which one (1.4 %) in the mesh group. No infection of the mesh occurred. Most of the other infections were infections of the perineal wound, equally distributed over both groups. No statistical differences were discovered in stoma or mesh-related complications, fistula or stricture formation, pain, or quality of life. CONCLUSIONS: During open and elective formation of an end-colostomy, primary placement of a retromuscular light-weight polypropylene mesh for prevention of a parastomal hernia is a safe and feasible procedure. The PREVENT trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018 .

Consequence of restaging after neoadjuvant treatment for locally advanced rectal cancer.

BACKGROUND: Locally advanced rectal cancer is customarily treated with neoadjuvant chemoradiotherapy (CRT) followed by a total mesorectal excision. During the course of CRT, previously non-detectable distant metastases can appear. Therefore, a restaging CT scan of the chest and abdomen was performed prior to surgery. The aim of this study was to determine the frequency of a change in treatment strategy after this restaging CT scan. METHODS: Patients treated with neoadjuvant CRT for locally advanced rectal cancer between January 2003 and July 2013 were included retrospectively. To determine the value of the restaging CT scan, the surgical treatment as planned before CRT was compared with the treatment ultimately received. RESULTS: A total of 153 patients (91 male) were eligible, and median age was 62 (32-82) years. The restaging CT scan revealed the presence of distant metastases in 19 patients (12.4, 95 % confidence interval [CI] 7.0-17.8). In 17 patients (11.1, 95 % CI 6.1-16.1), a change in treatment strategy occurred due to the detection of metastases with a restaging CT scan. CONCLUSION: A restaging CT scan after completion of neoadjuvant CRT may detect newly developed metastases and consequently alter the initial treatment strategy. This study demonstrated the added value of the restaging CT scan prior to surgery.

Feasibility study of three-nerve-recognizing Lichtenstein procedure for inguinal hernia.

BACKGROUND: Inguinal nerve identification during open inguinal hernia repair is associated with less chronic postoperative pain. However, most Dutch surgeons do not identify all three inguinal nerves when carrying out this procedure. The aim of this study was to evaluate the feasibility of a nerve-recognizing Lichtenstein hernia repair and to measure the extra time required for surgery METHODS: Forty patients with primary inguinal hernia were operated on following the nerve-recognizing Lichtenstein hernia repair by four experienced hernia surgeons from four different Dutch teaching hospitals. The additional time needed to identify each individual nerve was recorded, and iatrogenic nerve injuries and anatomical characteristics were registered. RESULTS: Identification of the iliohypogastric and ilioinguinal nerves was each performed within 1 min. Identification of the genital branch of the genitofemoral nerve was notably more difficult but could usually be performed within 2 min. Identification of the cremasteric vein, running parallel to the genital branch, was less comprehensive. The incidence of major anatomical variations was low. Twenty-five per cent of ilioinguinal nerves, however, could not be identified. In five patients inguinal nerves were damaged iatrogenically during standard manoeuvres of the Lichtenstein hernia repair. CONCLUSION: Three-nerve-recognizing Lichtenstein hernia repair is feasible and non-time consuming if the surgeon has appropriate anatomical knowledge. In view of the low incidence of major anatomical variations, knowledge of standard inguinal nervous anatomy should be adequate. This procedure could enable the surgeon to prevent or recognize iatrogenic nerve damage and offer an opportunity to perform deliberate neurectomy as an alternative to accidental nerve injury.

Bilateral round ligament varicosities mimicking inguinal hernia during pregnancy.

Round ligament varicosities during pregnancy have not been reported extensively. The swelling mimics an inguinal hernia and should be considered in the differential diagnosis of a groin swelling during pregnancy. We report a case of a pregnant woman with bilateral round ligament varicosities. At 22 weeks of pregnancy she was operated on based on the clinical suspicion of a painful inguinal hernia on the right side. Surgical exploration revealed varicosities of the round ligament, and resection was performed. Four weeks later the same diagnosis was made by duplex sonography of a painful swelling in the left groin. Increased pain necessitated surgical exploration and resection of the varicosities on the left side. The postoperative course on both sides was uneventful and without pain during the rest of her pregnancy, during labor or post partum.

Surgical techniques preventing chronic pain after Lichtenstein hernia repair: state-of-the-art vs daily practice in the Netherlands.

BACKGROUND: Morbidity associated with open inguinal hernia repair (IH repair) mainly consists of chronic pain. The aim of this study was to identify possible disparities between state-of-the-art Lichtenstein repair, and its application in general practice. METHODS: A questionnaire was mailed to all surgeons and surgical residents (n = 1,374) in the Netherlands in February 2005. The objective was to determine the state of general practice with respect to technical steps during the Lichtenstein repair that are suggested to be involved in the development of chronic pain, as recently updated by Lichtenstein's successor, Amid. RESULTS: More than half of the respondents do not act according to the Lichtenstein guidelines with respect to surgical steps that are suggested to be involved with the origin of chronic pain of somatic origin. Compliance with Amid's guidelines with respect to the handling of the nerves is variable. Surgeons conducting high numbers of IH repair are more likely to operate according to the key principles of the state-of-the-art Lichtenstein repair. CONCLUSION: There is a substantial disparity between the state-of-the-art Lichtenstein repair and its application in general practice with respect to steps that are suggested to play a role in the origin of chronic groin pain.

Nerve-identifying inguinal hernia repair: a surgical anatomical study.

BACKGROUND: Pain syndromes of somatic and neuropathic origin are considered to be the main causes of chronic pain after open inguinal hernia repair. Nerve-identification during open hernia repair is suggested to be associated with less postoperative chronic pain. The aim of this study was to define clinically relevant surgical anatomical zones facilitating efficient identification of the three inguinal nerves during open herniorrhaphy. METHOD: Through dissection of 18 inguinal areas of embalmed and unembalmed human cadavers, identification zones were developed for the inguinal nerves (in particular for the genital branch of the genitofemoral nerve). RESULTS: The iliohypogastric nerve was identifiable running approximately horizontally and ventrally to the internal oblique muscle perforating the external oblique aponeurosis at a mean of 3.8 cm (range 2.5-5.5 cm) cranially from the external ring. When present, the ilioinguinal nerve was identifiable running ventrally and parallel to the spermatic cord, dorsally from the aponeurosis of the external oblique muscle. Identification of the genital branch of the genitofemoral nerve was more comprehensive. The course of the genital branch is laterocaudal at the level of the internal inguinal ring. CONCLUSION: Based on the newly defined identification zones, peroperative identification of all inguinal nerves is possible. Further research is warranted to assess clinical feasibility of these zones and to evaluate the influence of (facultative) division, preservation or omittance of the identification of inguinal nerves on the incidence of chronic pain.

[Quality of a non-subsidised multicentre randomised trial in non-academic hospitals; an audit]. / Kwaliteit van een ongefinancierde multicentrische gerandomiseerde trial in niet-academische ziekenhuizen; een audit.

OBJECTIVE: To determine whether a randomised clinical trial in general hospitals can be performed in a reliable way without financial support. DESIGN: Descriptive. METHOD: The trial involved 1040 patients in whom an inguinal hernia had been corrected with a propylene mat in the period 1998-2003. They were randomised to either a single dose of prophylactic antibiotics or a placebo. The primary outcome measure was 'wound infection during the 3 months after the operation'. The audit concerned 98 patients, chosen at random, for whom 3 investigators from an independent bureau collected data from the patient charts and study forms during 3 clinic visits in the period 2000-2003. Whether various quality criteria had been fulfilled was assessed on the basis of these data. RESULTS: In all 4 participating clinics, approval of the medical ethics assessment committees had been obtained. The trial protocol corresponded to the consent form. A proper informed consent was obtained from 63/98 patients (64%). The last (third) follow-up was missed in 23/98 patients (23%). During the trial, the patients who had missed this follow-up were contacted by telephone, which succeeded in 98%. The status and trial forms had been filled out completely and correctly with regard to the peroperative randomisation forms in 90% of the cases and with regard to the follow-up in 75% of the cases. The trial protocol was adhered to on almost every point. CONCLUSION: The data collection in the studied, not financed trial was adequate, probably as a result of the relatively simple questions posed, the easily determinable outcome measure and the efforts expended above and beyond the protocol.

Surgical treatment options for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome is a common disorder, for which several surgical treatment options are available. OBJECTIVES: To compare the efficacy of the various surgical techniques in relieving symptoms and promoting return to work and/or activities of daily living and to compare the occurrence of side-effects and complications, in patients suffering from carpal tunnel syndrome. SEARCH STRATEGY: We updated the searches in 2003. We conducted computer-aided searches of the trials register of the Cochrane Neuromuscular Disease Group (searched in July 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2003), MEDLINE (January 1966 to August 2003), EMBASE (January 1980 to August 2003) and tracked references in bibliographies. SELECTION CRITERIA: Randomised controlled trials comparing various surgical techniques for the treatment of carpal tunnel syndrome. DATA COLLECTION AND ANALYSIS: Two reviewers performed study selection, assessment of methodological quality and data abstraction independently of each other. MAIN RESULTS: Twenty-three studies were included in the review. The methodological quality of the trials was fair to good. However, the application of allocation concealment was mentioned explicitly in only one trial. Many studies failed to present the results in sufficient detail to enable statistical pooling. Pooling was also impeded by the vast variety of outcome measures that were applied in the various studies. None of the existing alternatives to standard open carpal tunnel release seem to offer better relief from symptoms in the short- or long-term. There was conflicting evidence about whether endoscopic carpal tunnel release resulted in earlier return to work and/or activities of daily living than open carpal tunnel release. REVIEWERS' CONCLUSIONS: There is no strong evidence supporting the need for replacement of standard open carpal tunnel release by existing alternative surgical procedures for the treatment of carpal tunnel syndrome.

Repair of large midline incisional hernias with polypropylene mesh: comparison of three operative techniques.

Polypropylene mesh is widely used for the reconstruction of incisional hernias that cannot be closed primarily. Several techniques have been advocated to implant the mesh. The objective of this study was to evaluate, retrospectively, early and late results of three different techniques, onlay, inlay, and underlay. The records of 53 consecutive patients with a large midline incisional hernia -- 25 women and 28 men, mean age 60.4 (range 28-94) -- were reviewed. Polypropylene mesh was implanted using the onlay technique in 13 patients, inlay in 23 patients, and underlay in 17 patients. Either the greater omentum or a polyglactin mesh was interponated between the mesh and the viscera. The records of these 53 patients were reviewed with respect to: size and cause of the hernia, pre- and postoperative mortality and morbidity, with special attention to wound complications. Patients were invited to attend the outpatient clinic at least 12 months after implantation of the mesh for physical examination of the abdominal wall. Postoperative complications occurred in 14 (26.4%) patients. The onlay technique had significantly more complications, as compared to both other techniques. Reherniation occurred in 15 (28.3%) patients. The reherniation rate of the inlay technique was significantly higher than after the underlay technique (44% vs 12%, P=0.03) and tended to be higher than the onlay technique (44% vs 23%, P=0.22). Repair of large midline incisional hernias with the use of a polypropylene mesh carries a high risk of complications and has a high reherniation rate. The underlay technique seems to be the better technique.

[The 'Inguinal Hernia' guideline of the Association of Surgeons of the Netherlands]. / Richtlijn 'Liesbreuk' van de Nederlandse Vereniging voor Heelkunde.

The 'Inguinal hernia' guideline was written over a period of two years by nine surgeons (including one epidemiologist) from all regions of the Netherlands with demonstrable clinical and scientific expertise in the area of inguinal surgery after a training course on 'The development of evidence-based guidelines'. A draft of the guideline was on the website of the Association of Surgeons of the Netherlands for a period of three months, during which time the members of the society could comment on its contents interactively. The guideline comprises chapters on risk factors and prevention, diagnostics, indications for treatment, treatment, day surgery, antibiotics, thrombosis prophylaxis, training, anaesthesia, postoperative pain control, complications, costs, aftercare, and specific aspects of inguinal hernia in children. For the treatment of adult patients a mesh technique is recommended. The Lichtenstein technique is recommended as the first choice for uncomplicated primary inguinal hernia. Laparo-endoscopic techniques can be used by trained teams for specific indications. Other techniques have not been compared with the current methods of treatment sufficiently. It is recommended that the operations be carried out in daycare and that the use of local anaesthesia should be considered more often. The diagnosis of inguinal hernia in a child is based on the physical examination. It is recommended that the surgeon should not rely solely on the history but confirm the presence of a hernia personally. The treatment of a paediatric inguinal hernia is always operative. Generally, the younger the child, the more urgent the operation because of the increased risk of incarceration in infants, particularly premature babies. There is no indication for routine exploration of the contralateral groin. If an incarcerated hernia cannot be reduced, emergency operation is necessary and referral to a paediatric surgical centre must be considered. The implementation and effectiveness of the guideline will be measured by taking an inventory of all inguinal hernia operations performed in the Netherlands before and after its publication.

Randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia.

BACKGROUND: The optimum method for inguinal hernia repair has not yet been determined. The recurrence rate for non-mesh methods varies between 0.2 and 33 per cent. The value of tension-free repair with prosthetic mesh remains to be confirmed. The aim of this study was to compare mesh and non-mesh suture repair of primary inguinal hernias with respect to clinical outcome, quality of life and cost in a multicentre randomized trial in general hospitals. METHODS: Between September 1993 and January 1996, all patients scheduled for repair of a unilateral primary inguinal hernia were randomized to non-mesh or mesh repair. The patients were followed up at 1 week and at 1, 6, 12, 18, 24 and 36 months. Clinical outcome, quality of life and costs were registered. RESULTS: Three hundred patients were randomized of whom 11 were excluded. Three-year recurrence rates differed significantly: 7 per cent for non-mesh repair (n = 143) and 1 per cent for mesh repair (n = 146) (P = 0.009). There were no differences in clinical variables, quality of life and costs. CONCLUSION: Mesh repair of primary inguinal hernia repair is superior to non-mesh repair with regard to hernia recurrence and is cost-effective. Postoperative complications, pain and quality of life did not differ between groups.

Surgical treatment options for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome is a common disorder, for which several surgical treatment options are available. However, there is no consensus on the most effective method of treatment. OBJECTIVES: To compare the efficacy of the various surgical techniques in relieving symptoms and promoting return to work and/or activities of daily living and to compare the occurrence of side-effects and complications in patients suffering from carpal tunnel syndrome. SEARCH STRATEGY: We conducted computer-aided searches of the Cochrane Controlled Trials Register (Cochrane Library, Issue 1, 2000), MEDLINE(searched January 1966-March 2000) and EMBASE (searched January 1988-February 2000), and tracked references in bibliographies. SELECTION CRITERIA: Randomised controlled trials comparing various surgical techniques for the treatment of carpal tunnel syndrome. DATA COLLECTION AND ANALYSIS: Study selection, assessment of methodological quality and data abstraction were performed by two reviewers independently of each other. MAIN RESULTS: Sixteen studies were included in the review. The methodological quality of the trials was fair to good. However, the application of allocation concealment was mentioned explicitly in only two trials. Many studies failed to present the results in sufficient detail to enable statistical pooling. Pooling was also impeded by the vast variety of outcome measures that were applied in the various studies. None of the existing alternatives to standard open carpal tunnel release seem to offer better relief from symptoms in the short- or long-term. There is conflicting evidence about whether endoscopic carpal tunnel release results in earlier return to work and/or activities of daily living than open carpal tunnel release. REVIEWER'S CONCLUSIONS: There is no strong evidence supporting the need for replacement of standard open carpal tunnel release by existing alternative surgical procedures for the treatment of carpal tunnel syndrome.

Systematic review of randomized clinical trials of surgical treatment for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a common disorder for which several surgical treatment options are available. However, there is no consensus on the most effective method of treatment. The object of this systematic review is to compare the efficacy of the various surgical techniques in relieving the symptoms of CTS and promoting return to work and/or activities of daily living. METHODS: Computer-aided searches of Medline, EMBASE and the Cochrane Controlled Trials Register were conducted, together with reference checking. A rating system, based on the number of studies and their methodological quality and findings, was used to determine the strength of the available evidence for the efficacy of the treatment. RESULTS: Fourteen studies were included in the review. None of the alternatives to standard open carpal tunnel release (OCTR) seems to offer better relief of symptoms. There is conflicting evidence about whether endoscopic carpal tunnel release results in earlier return to work and/or activities of daily living. CONCLUSION: Standard OCTR is still the preferred method of treatment for CTS. It is just as effective as the alternatives, but is technically less demanding, so incurs a lower risk of complications and of added costs.

Inguinal hernia repair in the Amsterdam region 1994-1996.

In the Netherlands, approximately 30,000 inguinal hernia repairs are performed yearly. At least 15% are for recurrence. New procedures are being introduced creating discussion on which technique is the best. Currently it is not possible to choose on evidence alone because of the long follow-up that is needed. In 1996 an inventory was taken of all inguinal hernia repairs that were performed in the Amsterdam region (9 hospitals). These results were compared with the results from a similar study performed in 1994. Major changes in treatment strategy were noted. The Bassini repair was replaced by Shouldice and Lichtenstein techniques. There was a significant increase in the use of prostheses for both primary and recurrent inguinal hernias. There was no significant decrease in the percentage of operations performed for recurrent hernia from 19.5% to 16.8%. However, there was a significant decrease in operations performed for early recurrences (5.1%-3.4%) (p = 0.05). These results suggest that the Shouldice and Lichtenstein repairs may be superior to the Bassini repair in terms of early hernia recurrence.

Follow-up after inguinal hernia repair. Questionnaire compared with physical examination: a prospective study in 299 patients.

OBJECTIVE: To assess the value of a written questionnaire in the follow-up of patients after inguinal hernia repair. DESIGN: Prospective study. SETTING: University and two district hospitals. The Netherlands. SUBJECTS: 314 patients with 362 inguinal hernias. MAIN OUTCOME MEASURES: Correlation between answers to questionnaire and clinical examination in the diagnosis of recurrent hernias. RESULTS: 13/24 recurrences (54%) after a mean follow-up of 33 months with a follow-up rate of 93% were not diagnosed by the questionnaire. CONCLUSION: Follow-up after hernia repair must be by physical examination.

[More recurrencies than expected following inguinal hernia surgery]. / Meer recidieven na liesbreukchirurgie dan verwacht.

OBJECTIVE: To make an inventory of inguinal hernia repairs performed in one year, and to analyse the number of and origin of recurrent hernias. DESIGN: Retrospective. SETTING: Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. METHOD: Analysis of all hernia operations performed in Amsterdam and Amstelveen in 1994 in male patients over 18 years of age. Request of national data, computer data from the hospitals, hand count of all operation reports and investigation of patient files. RESULTS: In 1994, 1108 patients were operated for inguinal hernia on one or two sides. In 216/1108 (19.5%) cases recurrent hernia was involved. According to national statistics this occurred in 175/1123 (15.6%). In the two University hospitals 25.7% of all repairs were for a recurrent hernia, in the two hospitals with a surgical training programme this proportion was 17.9% and in the five hospitals without a training programme it was 18.6%. Of the early recurrences (within two years) 82.5% (47/57) were reoperated in the same hospital as before but of the late recurrences (more than 10 years) this proportion was only 26.8%. Only 16.6% (36/216) of the patients with a recurrence were reoperated by the same surgeon who had performed the prior operation. Most popular method for repair was a Bassini (59%). In the training hospitals more early recurrences were repaired than in the non-training hospitals. CONCLUSION: The percentage of hernia repairs for recurrent hernia is higher than national statistics suggest and higher than expected. Surgeons have little insight into their performance as many recurrences are repaired by another surgeon and many recurrences occur after ten years. Better training and more use of modern techniques may improve results.

Role of the Shouldice technique in inguinal hernia repair: a systematic review of controlled trials and a meta-analysis.

The Shouldice technique for inguinal hernia repair has been suggested by some authors as the best conventional method against which other methods using prostheses should be compared. The paper which follows is a systematic review involving a comprehensive search of the medical literature to identify all clinical trials (article or abstract) evaluating the Shouldice repair. After assessment of certain quality criteria, the best studies were pooled in a meta-analysis. Nine publications were found with 11 study arms. In ten studies the results of the Shouldice technique were better than the results of the control arm. Six studies could be pooled in a meta-analysis of 2500 patients; Shouldice was significantly better than control methods (relative risk 0.62 (95 per cent confidence interval 0.45-0.85)). In spite of possible bias caused by different variables (modifications in operative technique, suture material, level of surgeon, follow-up methods and outcome measurement), the results of this systematic review suggest that the Shouldice method is the best current conventional technique for inguinal hernia repair.

Long-term results of giant prosthetic reinforcement of the visceral sac for complex recurrent inguinal hernia.

The results of recurrent inguinal hernia repair in a prospective cohort study were evaluated. From May 1986 to December 1990 75 patients with 150 hernias (24 primary, 126 recurrent) were operated using a technique based on Stoppa's preperitoneal mesh repair (giant prosthetic reinforcement of the visceral sac; GPRVS). All patients were at high risk for recurrence: they all had bilateral hernias, mostly bilateral recurrent and often repeatedly recurrent. All patients had a physical examination 1 week, 6 weeks and 1 year after operation. Sixty patients (94 per cent of surviving patients) had a physical examination after a mean follow-up of 5.7 (range 4-9) years. There were no major complications. There was one deep infection that healed without removing the mesh. One of the 75 patients (1 per cent) had a recurrence 2 months after the operation, due to a technical failure. Because of the excellent results, the ease of the procedure and the low complication rate, GPRVS is the authors' operation of choice for any recurrent inguinal hernia.