Use of Prophylactic Mesh When Creating a Colostomy Does not Prevent Parastomal Hernia

A Randomized Controlled Trial-STOMAMESH

Christoffer Odensten, MD; Karin Strigård, MD, PhD; Jörgen Rutegård, MD, PhD; Michael Dahlberg, MD, PhD; Ulrika Ståhle, MD; Ulf Gunnarsson, MD, PhD; Pia Näsvall, MD, PhD

Disclosures

Annals of Surgery. 2019;269(3):427-431. 

In This Article

Abstract and Introduction

Abstract

Objective: The aim of this study was to determine whether parastomal hernia (PSH) rate can be reduced by using synthetic mesh in the sublay position when constructing permanent end colostomy. The secondary aim was to investigate possible side-effects of the mesh.

Background: Prevention of PSH is important as it often causes discomfort and leakage from stoma dressing. Different methods of prevention have been tried, including several mesh techniques. The incidence of PSH is high; up to 78%.

Methods: Randomized controlled double-blinded multicenter trial. Patients undergoing open colorectal surgery, including creation of a permanent end colostomy, were randomized into 2 groups, with and without mesh. A lightweight polypropylene mesh was placed around the colostomy in the sublay position. Follow up after 1 month and 1 year. Computerized tomography and clinical examination were used to detect PSH at the 1-year follow up. Data were analyzed on an intention-to-treat basis.

Results: After 1 year, 211 of 232 patients underwent clinical examination and 198 radiologic assessments. Operation time was 36 minutes longer in the mesh arm. No difference in rate of PSH was revealed in the analyses of clinical (P = 0.866) and radiologic (P = 0.748) data. There was no significant difference in perioperative complications.

Conclusions: The use of reinforcing mesh does not alter the rate of PSH. No difference in complication rate was seen between the 2 arms. Based on these results, the prophylactic use of mesh to prevent PSH cannot be recommended.

Introduction

Parastomal hernia (PSH) is a common complication after stomal surgery. Though the exact incidence has not been fully established, figures range between a few and 78%.[1–3] Most PSHs develop within 2 years of surgery but can occur up to 30 years later. Approximately, one third of patients operated for rectal cancer in Sweden have a permanent colostomy, and 24% to 39% of patients with a "temporary" stoma never have it reversed.[4–6] PSH causes difficulties with stoma dressing and leakage, increases the risk for incarceration, and has a negative impact on the patient's quality of life.[7–9]

A number of strategies have been proposed to prevent the formation of PSH after primary surgery: choice of stoma placement through versus lateral to the rectus sheath, transperitoneal versus extraperitoneal, and correct sizing of the trephine.[2,10] None of these seems to reduce the incidence of PSH. Furthermore reported 30-day morbidity and mortality rates of planned repair procedures are 8% to 36% and 0% to 5%, respectively[11–13] Emergency PSH repair has a reported mortality rate of 11% to 25%.[14,15] The development of stoma techniques that reduce the risk for PSH is thus a field of research that should be given priority.

Placement of a mesh to prevent PSH formation has been proposed. Eight small and 2 large randomized controlled trials (RCT) have been published during the past 2 decades. Pooled data from these studies show promising results,[16] though mesh location, choice of mesh material and surgical approach varied.[17–23] The use of mesh did not increase complication rate, but none of the trials was designed to assess complication. On the contrary, 1 retrospective trial comparing PSH rate before and after the introduction of routine prophylactic mesh around the stoma, at a unit that repeatedly produced top results in the Swedish Rectal Cancer Registry, showed no difference in complication rates between groups.[24] The Swedish National Board of Health and Welfare classifies the use of prophylactic mesh around stomas as, "Research and Development," because of the weak scientific evidence; larger RCTs comparing prophylactic mesh with no mesh are required.[25]

In view of this uncertainty, we designed a double-blinded multicenter RCT to evaluate the effects of using a prophylactic mesh around the stoma. The primary aim was to evaluate the PSH rate in both groups, and a secondary aim was to assess the risk for early complications. Our hypothesis was that polypropylene mesh in the sublay position around a colostomy decreases the risk for PSH.

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