Role of Prosthetic Mesh in Preventing Parastomal Hernias

Summary

Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3).

Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8).

The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support.

Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro.

Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique.

Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period.

Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.

Conditions

• Parastomal Hernia

Interventions

DEVICE

Definitive end colostomy with mesh

In the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures.

OTHER

Conventional definitive end colostomy

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  lead OTHER

Principal Investigators

• Eduardo Targarona, MD · Hospital de Santa Creu i Sant Pau, Barcelona, Spain

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2015-10-31

Completion

2016-10-31

Countries

• Spain

Study Locations