Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial
| Autor: | Robert P. Bleichrodt, D. van Geldere, Camiel Rosman, F M van Lammeren, Henk-Thijs Brandsma, Pascal Steenvoorde, J.H.W. de Wilt, Theo J Aufenacker, T. S. de Vries Reilingh, Chander Mahabier, Birgitta M E Hansson, R J Wiezer |
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| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment 030230 surgery law.invention Abdominal wall Prosthesis Implantation 03 medical and health sciences Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] 0302 clinical medicine Randomized controlled trial law Colostomy Clinical endpoint medicine Humans Hernia Prospective Studies Aged business.industry Abdominal Wall Surgical Stomas Middle Aged Surgical Mesh medicine.disease Hernia Ventral Colostomy Site Surgery medicine.anatomical_structure Trephine 030220 oncology & carcinogenesis Feasibility Studies Female business Abdominal surgery |
| Zdroj: | Hernia, 20, 4, pp. 535-41 Europe PubMed Central Hernia, 20, 535-41 |
| ISSN: | 1265-4906 |
| Popis: | 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 . |
| Databáze: | OpenAIRE |
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