Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial

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