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Aim To determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term. Material and Methods In this multicenter superiority trial patients undergoing formation of a permanent colostomy were randomly assigned to either retromuscular mesh reinforcement or conventional colostomy formation. The primary endpoint was the incidence of a PSH after 5 years. Secondary endpoints were morbidity, mortality, quality of life and cost-effectiveness. Results A total of 150 patients were randomly assigned to the mesh group (n = 72) or non-mesh group (n = 78). For the long term follow up, we could analyse 113 patients since 37 patients were lost to follow-up. After a median follow-up of 60 months (IQR 48.6 – 64.4), 49 patients developed a PSH, 20 (27.8%) in the mesh group and 29 (37.2%) in the non-mesh group (p = 0.22; 95% CI -24 – 5.5). A total of 25 patients developed an incisional hernia, seven in the mesh group (10.4%) versus 18 in the non-mesh group (27.2%) (p = 0.013, 95% CI 3.5 – 30.0). No relevant differences were found in quality of life or cost-effectiveness between both study group. Conclusions Use of a prophylactic retromuscular mesh at the ostomy site delays but not reduces the incidence of PSH after 5 years of follow-up. It leads to less severe PSH according to the EHS and MM classification with fewer repairs needed. Furthermore it causes patients to have fewer stoma related complications necessitating change of appliances and it is safe without any adverse events or increase in morbidity.

Contains fulltext : 175643.pdf (Publisher’s version ) (Closed access) OBJECTIVE: The aim of this study was to investigate the incidence of parastomal hernias (PSHs) after end-colostomy formation using a polypropylene mesh in a randomized controlled trial versus conventional colostomy formation. BACKGROUND: A PSH is the most frequent complication after stoma formation. Symptoms may range from mild abdominal pain to life-threatening obstruction and strangulation. The treatment of a PSH is notoriously difficult and recurrences up to 20% have been reported despite the use of mesh. This has moved surgical focus toward prevention. METHODS: Augmentation of the abdominal wall with a retro-muscular lightweight polypropylene mesh was compared with the traditional formation of a colostomy. In total, 150 patients (1:1 ratio) were included. The incidence of a PSH, morbidity, mortality, quality of life, and cost-effectiveness was measured after 1 year of follow-up. RESULTS: There was no difference between groups regarding demographics and predisposing factors for PSH. Three out of 67 patients (4.5%) in the mesh group and 16 out of 66 patients (24.2%) in the nonmesh group developed a PSH (P = 0.0011). No statistically significant difference was found in infections, concomitant hernias, SF-36 questionnaire, Von Korff pain score, and cost-effectiveness between both study groups. CONCLUSION: Prophylactic augmentation of the abdominal wall with a retromuscular lightweight polypropylene mesh at the ostomy site significantly reduces the incidence of PSH without a significant difference in morbidity, mortality, quality of life, or cost-effectiveness.

Contains fulltext : 171283.pdf (Publisher’s version ) (Closed access) 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 .

Background: With established protocols lacking, the choice of anesthetic technique remains arbitrary in inguinal hernia repair. Well-designed studies in this subject are important because of the gap or discrepancy between available scientific evidence and clinical practice. Methods: Between August 2004 and June 2006, a multicenter prospective clinical trial was performed in which 100 patients with unilateral primary inguinal hernia were randomized to spinal or local anesthesia. Clinical examination took place within 2 weeks postoperatively and at 3 months in the outpatient clinic. Results: Analysis of postoperative visual analogue scale scores showed that patients operated under local anesthesia had significant less pain shortly after surgery (P = 0.021). Significantly more urinary retention (P < 0.001) and more overnight admissions (P = 0.004) occurred after spinal anesthesia. Total operating time is significantly shorter in the local anesthesia group (P < 0.001). No significant differences were found between the 2 groups with respect to the activities of daily life and quality of life. Conclusions: Our study provides evidence that local anesthesia is superior to spinal anesthesia in inguinal hernia repair. Local anesthesia in primary, inguinal hernia repairs should be the method of choice.