H T Brandsma1, B M E Hansson2, T J Aufenacker3, D van Geldere4, F M van Lammeren5, C Mahabier6, P Steenvoorde7, T S de Vries Reilingh8, R J Wiezer9, J H W de Wilt10, R P Bleichrodt2, C Rosman2. 1. Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands. henkthijs@hotmail.com. 2. Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands. 3. Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands. 4. Department of Surgery, Isala Clinics, Zwolle, The Netherlands. 5. Department of Surgery, Slingeland Hospital, Doetinchem, The Netherlands. 6. Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands. 7. Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands. 8. Department of Surgery, Elkerliek Hospital, Helmond, The Netherlands. 9. Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands. 10. Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
Abstract
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 .
RCT Entities:
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 .
Authors: Henk-Thijs Brandsma; Birgitta M E Hansson; Hilde V-Haaren-de Haan; Theo J Aufenacker; Camiel Rosman; Rob P Bleichrodt Journal: Trials Date: 2012-11-27 Impact factor: 2.279
Authors: S A Antoniou; F Agresta; J M Garcia Alamino; D Berger; F Berrevoet; H-T Brandsma; K Bury; J Conze; D Cuccurullo; U A Dietz; R H Fortelny; C Frei-Lanter; B Hansson; F Helgstrand; A Hotouras; A Jänes; L F Kroese; J R Lambrecht; I Kyle-Leinhase; M López-Cano; L Maggiori; V Mandalà; M Miserez; A Montgomery; S Morales-Conde; M Prudhomme; T Rautio; N Smart; M Śmietański; M Szczepkowski; C Stabilini; F E Muysoms Journal: Hernia Date: 2017-11-13 Impact factor: 4.739