Primary Prevention of Peristomial Hernias Via Parietal Prostheses

Not Applicable

Completed

• Conditions: Parastomal Hernia

• Registration Number: NCT01380860
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

Detailed Description

Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.

Study Timeline

• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Study Start: 2012-11
• Primary Completion: 2016-10-20
• Study Completion: 2018-10-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• The patient has given informed consent
• The patient must be affiliated with a health insurance programme
• The patient must be available for 24 months of follow-up
• The patient requires a colostomy (primo-event, ie first colostomies only)

Exclusion Criteria

• The patient is currently participating in another interventional study
• The patient is in an exclusion period determined by a previous study
• The patient is under guardianship
• The patient refuses to sign the consent
• It is impossible to communicate information to the patient (does not read French)
• The patient is pregnant
• The patient is breastfeeding
• There is a contra-indication for any treatment used in this study
• The subject has already had a colostomy
• The subject has peritonitis
• The subject needs a colostomy for infectious reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence/absence of a peristomal hernia	24 months	The occurrence of peristomal hernias is determined in both groups every three months up until 24 months. The presence of absence of a hernia is detected by clinical exam, and at 24 months by an additional radiology exam. The primary outcome concerns rates at 24 months, primo-events only.

Secondary Outcome Measures

Name	Time	Method
Presence/absence of peristomal hernia	21 months	The presence of absence of a hernia is detected by clinical exam.
Days of hospitalisation	1 month	The number of days spent in the hospital after the surgical intervention.
Estimation of blood loss during the operation (ml)	Day 1
Was stomal repair necessary for the patient? yes/no	24 months
Was relocation of the colostomy required? yes/no	24 months
Presence/absence of complications	21 months	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Patient difficulty for fitting his/her colostomy with the appropriate sac.	21 months	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
Pain around the colostomy	21 months	A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Abdominal pain	21 months	A visual analog scale is used to assess the patient's perception of abdominal pain.
Pain medication consumption	21 months
Number of colostomy leaks per day	21 months
Presence/absence of a complication potentially linked to the presence of a mesh?	24 months
Number of colostomy sac changes per day	21 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no	21 months
Questionnaire Stoma-QOL	1 month	Validated assessment of quality of life.
Exposition of the prothesis (mesh): yes/no	21 months
Presence/absence of peri-operative complications	Day 1
Ablation of the mesh: yes/no	24 months
Evaluation of colostomy healing by the clinician	24 months	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Duration of postoperative fever (hours)	10 days
Presence/absence of postoperative fever > 37.2°C	Day 1
Operating time (minutes)	Day 1

Trial Locations

Locations (22)

CHRU de Besancon; 🇫🇷 Besancon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHRU de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

APHP - Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Albert Michallon, CHU de Grenoble; 🇫🇷 Grenoble, France

APHP - Centre Hospitalier Universitaire de Bicêtre; 🇫🇷 Le Kremlin Bicêtre Cedex, France

CHRU de Lille - Hôpital Claude Huriez; 🇫🇷 Lille Cedex, France

Centre de Lutte Contre le Cancer - Centre Oscar Lambret; 🇫🇷 Lille, France

CHU de Lyon; 🇫🇷 Lyon, France

Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes; 🇫🇷 Marseille, France

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