Primary Prevention of Peristomial Hernias Via Parietal Prostheses
- Conditions
- Parastomal Hernia
- Interventions
- Procedure: Simple colostomyProcedure: Colostomy with mesh implantation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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
- Arm && Interventions
Group Intervention Description No mesh Simple colostomy The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy. Mesh Colostomy with mesh implantation The patients allocated to this arm of the study will have mesh (Covidien France: mono filament polyester bidimensional knit) implanted in association with their colostomy.
- 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 Operating time (minutes) Day 1 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.
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.
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
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
Trial Locations
- Locations (22)
APHP - Hôpital Saint-Antoine
🇫🇷Paris Cedex 12, France
Hôpital Albert Michallon, CHU de Grenoble
🇫🇷Grenoble, France
APHP - Centre Hospitalier Universitaire de Bicêtre
🇫🇷Le Kremlin Bicêtre Cedex, France
CHRU de Besancon
🇫🇷Besancon, France
CHU de Bordeaux
🇫🇷Bordeaux, France
APHP - Hôpital Beaujon
🇫🇷Clichy, France
CHRU de Clermont Ferrand
🇫🇷Clermont Ferrand, France
CHU de Lyon
🇫🇷Lyon, France
CHU de Rouen
🇫🇷Rouen, France
Hôpital Pontchailou
🇫🇷Rennes, France
CHRU de Lille - Hôpital Claude Huriez
🇫🇷Lille Cedex, France
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
🇫🇷Lille, France
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
🇫🇷Marseille, France
APHM - Hôpital La Timone Adultes
🇫🇷Marseille, France
Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
Centre Hospitalier Universitaire de Nîmes
🇫🇷Nîmes, France
APHP - Hôpital Lariboisière
🇫🇷Paris, France
CH de Vichy - Jacques Larin
🇫🇷Vichy, France
CHU de Toulouse
🇫🇷Toulouse, France
APHP - Groupe Hospitalier Pitié-Salpetrière
🇫🇷Paris Cedex 13, France
Centre Régional de Lutte contre le Cancer Centre Paul Strauss
🇫🇷Strasbourg, France