Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

Recruiting

• Conditions: Colostomy Stoma; Parastomal Hernia

• Registration Number: NCT04282473
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Study Start: 2022-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• The patient must be affiliated with a health insurance programme
• Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
• Patient received colostomy 5 years ago

Exclusion Criteria

• The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
• The subject signals opposition to participating in the study
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant or breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of parastomal hernia between groups	5 years after colostomy formation	Percentage patients with parastomal hernia taken from patient medical records
Date of parastomal hernia	5 years after colostomy formation	Date of parastomal hernia taken from patient records

Secondary Outcome Measures

Name	Time	Method
Protrusion around the stoma	5 years after colostomy formation	Yes/no
Patient reported pain	5 years after colostomy formation	Yes/no
Incarceration	5 years after colostomy formation	Yes/no
Cost of patients care	5 years after colostomy formation	Euros
Discomfort	5 years after colostomy formation	0-100 scale (very uncomfortable to very comfortable)
Number of medications taken in each group	5 years after colostomy formation	Number of medications taken
Occlusion	5 years after colostomy formation	Yes/no
Patient reported quality of life	5 years after colostomy formation	Stoma-QoL questionnaire - a 20-item questionnaire on a four-point Likert scale with total score ranging from 0 (worst score) to 100 (best score)
Other associated treatment received by patients in each group	5 years after colostomy formation	number of treatments received
Rehabilitation sessions undergone by patients in each group	5 years after colostomy formation	number of rehabilitation sessions
Sick leave taken by patients in each group	5 years after colostomy formation	Number of days
Pain at colostomy site	5 years after colostomy formation	0-100 scale (no pain to intolerable pain)
Patient reported satisfaction	5 years after colostomy formation	0-100 scale (not at all satisfied to very satisfied)
Number of specialist and general consultations attended by patients between groups	5 years after colostomy formation	number of consultations

Trial Locations

Locations (16)

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospitalier Lyon-Sud; 🇫🇷 Lyon, France

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

Hôpital Purpan - CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Nimes; 🇫🇷 Nîmes, France

Hôpital Charles-Nicolle; 🇫🇷 Rouen, France

Hôpital Saint Antoine (AP-HP); 🇫🇷 Paris, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

L'Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHRU Clermont- Ferrand Hôtel -Dieu; 🇫🇷 Clermont-Ferrand, France

Hôpital Beaujon (AP-HP); 🇫🇷 Clichy, France

Hôpital Albert Michallon; 🇫🇷 Grenoble, France

CRLC Val d'Aurelle - Paul Lamarque; 🇫🇷 Montpellier, France

Hôpital La Timone, AP-HM; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes; 🇫🇷 Nantes, France