Simon Näverlo1, Ulf Gunnarsson2, Karin Strigård2, Pia Näsvall2,3. 1. Department of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 88, Umeå, Sweden. simon.naverlo@umu.se. 2. Department of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 88, Umeå, Sweden. 3. Sunderby Research Unit, Umeå University, Luleå, Sweden.
Abstract
PURPOSE: To determine whether prophylactic mesh in a sublay position has an impact on the quality-of-life (QoL) of patients receiving an end colostomy. METHODS: One-year follow-up of patients from the STOMAMESH trial, a randomized controlled double-blinded multicenter study. Patients were randomized to either prophylactic synthetic mesh with a cruciform incision in the center, placed in sublay position, or no prophylactic mesh. Patients attended a 1-year visit and responded to the questionnaires EORTC QLQ C-30 and CR-38. The impact of having a mesh on QoL was determined by comparing a group of patients receiving a mesh with a group without. A subgroup analysis was made depending on whether a PSH was clinically present or not. RESULTS: Of the 232 randomized patients, 211 patients reached the 1-year clinical follow-up. The response rate of these 211 patients was 70%. No differences were seen in global QoL between the groups. Mesh patients reported significantly less stoma-related problems (p = 0.014) but more sexual problems in males (p = 0.022). When excluding patients with a clinical diagnosis of PSH, the difference in stoma-related problems remained while no significant difference was seen regarding sexual problems in males. CONCLUSIONS: When forming an end colostomy, prophylactic synthetic mesh in a sublay position did not affect global QoL at 1-year follow-up, but stoma-related problems were fewer even in the presence of a clinically diagnosed PSH. TRIAL REGISTRATION: NCT00917995.
RCT Entities:
PURPOSE: To determine whether prophylactic mesh in a sublay position has an impact on the quality-of-life (QoL) of patients receiving an end colostomy. METHODS: One-year follow-up of patients from the STOMAMESH trial, a randomized controlled double-blinded multicenter study. Patients were randomized to either prophylactic synthetic mesh with a cruciform incision in the center, placed in sublay position, or no prophylactic mesh. Patients attended a 1-year visit and responded to the questionnaires EORTC QLQ C-30 and CR-38. The impact of having a mesh on QoL was determined by comparing a group of patients receiving a mesh with a group without. A subgroup analysis was made depending on whether a PSH was clinically present or not. RESULTS: Of the 232 randomized patients, 211 patients reached the 1-year clinical follow-up. The response rate of these 211 patients was 70%. No differences were seen in global QoL between the groups. Mesh patients reported significantly less stoma-related problems (p = 0.014) but more sexual problems in males (p = 0.022). When excluding patients with a clinical diagnosis of PSH, the difference in stoma-related problems remained while no significant difference was seen regarding sexual problems in males. CONCLUSIONS: When forming an end colostomy, prophylactic synthetic mesh in a sublay position did not affect global QoL at 1-year follow-up, but stoma-related problems were fewer even in the presence of a clinically diagnosed PSH. TRIAL REGISTRATION: NCT00917995.
Authors: L Påhlman; M Bohe; B Cedermark; M Dahlberg; G Lindmark; R Sjödahl; B Ojerskog; L Damber; R Johansson Journal: Br J Surg Date: 2007-10 Impact factor: 6.939