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

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 stomarelated 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 1year follow-up, but stoma-related problems were fewer even in the presence of a clinically diagnosed PSH. Trial registration NCT00917995

Use of prophylactic mesh during initial stoma creation to prevent parastomal herniation: a systematic review and meta‐analysis of randomised controlled trials

“…Public and patient involvement in study design is now acknowledged by many funders as being of paramount importance in ensuring that the questions that matter to patients are answered, but its absence is conspicuous in the context of PSH research. Since the indication for elective PSH repair is to improve quality of life, it is notable that only one RCT has reported data relating to this outcome [9]. Patient reported outcome measures relating to PSH symptoms have not been detailed in the RCTs, but this may be because the available tools were lacking or were only published after the studies were planned and were recruiting [62].…”

“…Although the exact incidence of PSH has not been fully established, estimates range between 20% and 50%, depending on the length of follow-up, stoma type and diagnostic method [2][3][4][5][6]. Symptoms of PSH can adversely affect patients' health-related quality of life [7][8][9][10]. PSH can cause pain, stoma appliance leakage and peristomal skin irritation [11,12], and can lead to unplanned hospital admissions due to bowel obstruction, strangulation or perforation [6,13].…”

Abdominal Wall Reconstruction and Parastomal Hernia Repair

“…Some would even pessimistically contend that with long enough follow-up, PSH development is inevitable [4]. In addition to pain and potential obstructive symptoms akin to all incisional hernias, PSH bulging can also cause pouching dysfunction with a devastating impact on these patients' quality of life (QoL), not to mention the financial burden of additional supplies and frequent need for hospital readmission to break the cycle of appliance leakage and worsening skin excoriation [5,6]. Consequently, both the American Society of Colon and Rectal Surgeons and the Association of Coloproctology of Great Britain and Ireland have identified PSH prevention and repair as a top research priority [7,8].…”

A semi‐Markov model comparing the lifetime cost‐effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer

“…PSH may be asymptomatic or symptomatic [7][8][9]. Symptoms of PSH can negatively affect patients' health-related quality-of-life [9][10][11][12] due to pain, stoma leakage due to poorly-fitting stoma appliances and skin irritation [13,14], and limit their social interaction and ability to work [8,12]. PSH can also cause serious problems such as bowel obstruction or strangulation which may require emergency treatment in hospital [6,15].…”