Prevention of a hernia next to a stoma with a prosthetic mesh.

Prevention of parastomal hernia with a prosthetic mesh, a multicenter randomized controlled trial.

Aim: Does the use of a monofilament polypropylene mesh in a sublay position during the creation of a colostomy reduce the incidence of parastomale hernia?

Introduction: Treatment of a parastomal hernia remains a difficult problem. One trial (54 patients) demonstrated a beneficial effect of prophylactic placement of a mesh during the formation of a colostomy. But in this trial the follow-up was relatively short and it was prematurely stopped. Until now
the use of a prophylactic mesh is not a standard treatment (in the Netherlands).

Methods: Prospective randomised (single blind) multicentre trial.

Population: Patients with an elective suspected permanent colostomy between the age of 18 and 80 will be asked
to participate unless there is a life expectancy of less than 12 months.

Intervention: A lightweight partially absorbable monofilament polypropylene mesh placed in a sublay
positions as described by Israelsson is compared with a colostomy without a mesh.

Endpoint: The incidence of parastomal hernia with a follow-up after 3 weeks, 3 months, 1, 2 and 5 years.
Secondary
endpoints: cost effectiveness analysis, quality of life and pain scores.

Sample size: A reduction from 30% (non mesh) towards 10% (mesh group) parastomale hernia is expected.
Based on a p-value of 0.05 (alfa), a power of 90% (beta) and a two-sided test 134 patients areneeded. A total of 150 patients will be included with 75 patients in each trial arm
Inclusion time: 11 academic and training hospitals will participate in the inclusion. The inclusion should
be completed after 18 months. The first data analysis and first report will be after one year follow-up as
generally accepted in hernia research but follow-up will be completed after five years.

A lightweight monofilament polypropylene mesh in a sublay position reduces the incidence of a parastomal hernia.

3 weeks, 3 months, 1 year, 2 years and 5 years.

A lightweight monofilament polypropylene mesh placed in a sublay position is compared with formation of an end-colostomy without a mesh.