Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh

Summary

Background:

Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure.

Methods/Design:

The study will be a randomized controlled single-blinded monocentric study determining the 1-year incidence of incisional hernia in cancer patients undergoing ileostomy or colostomy closure with or without prophylactic non-absorbable mesh applied in the sublay position.

Discussion:

Prevention of incisional hernia at site of stoma closure will lead to an improvement in patients' quality of life and generating savings for healthcare systems. To date, no randomized controlled trial assessing the effect of prophylactic mesh applied during stoma closure on the prevention of incisional hernia has been published. With the present randomized controlled trial, we expect to demonstrate that the application of a prophylactic mesh reduces the one-year incidence of incisional hernia at site of stoma closure.

Conditions

• Incisional Hernia

Interventions

DEVICE

Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position

* Antibioprophylaxis using cefuroxime and metronidazole * Standard disinfection and sterile draping * Circular incision around the stoma using the scalpel blade * Dissection around the stoma until entering the abdominal cavity * Closure of the stoma using a linear stapler * A midline laparotomy may be performed or not * Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis * Closure of the posterior aponeurosis using separate Maxon 2-0 stitches * Application of an ULTRAPRO Advanced Mesh, Ethicon, Johnson \& Johnson, with +2cm on the edges, secured by 4 stiches of Maxon 2-0 * Closure of the anterior aponeurosis using separate Maxon 2-0 stitches * No subcutaneous stitches * Partial purse string skin closure using Monocryl 3-0 * Standard wound dressing

PROCEDURE

Stoma closure without mesh

* Antibioprophylaxis using cefuroxime and metronidazole * Standard disinfection and sterile draping * Circular incision around the stoma using the scalpel blade * Dissection around the stoma until entering the abdominal cavity * Closure of the stoma using a linear stapler * A midline laparotomy may be performed or not * Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis * Closure of the posterior aponeurosis using separate Maxon 2-0 stitches * Closure of the anterior aponeurosis using separate Maxon 2-0 stitches * No subcutaneous stitches * Partial purse string skin closure using Monocryl 3-0 * Standard wound dressing

Sponsors & Collaborators

• University Hospital, Geneva

  lead OTHER

Principal Investigators

• Nicolas Buchs, MD, PD · University Hospitals of Geneva

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2024-05-31

Completion

2024-12-31

Countries

• Switzerland

Study Locations