Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
RESEDAE
1 other identifier
observational
134
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJune 25, 2024
June 1, 2024
2.9 years
February 21, 2020
June 24, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of parastomal hernia between groups
Percentage patients with parastomal hernia taken from patient medical records
5 years after colostomy formation
Date of parastomal hernia
Date of parastomal hernia taken from patient records
5 years after colostomy formation
Secondary Outcomes (14)
Protrusion around the stoma
5 years after colostomy formation
Patient reported pain
5 years after colostomy formation
Occlusion
5 years after colostomy formation
Incarceration
5 years after colostomy formation
Patient reported quality of life
5 years after colostomy formation
- +9 more secondary outcomes
Study Arms (2)
with mesh
Placement of lightweight (\<50g/m2) monofilament mesh during colostomy formation
no mesh
colostomy without mesh placement
Eligibility Criteria
The study population consists of patients included in the GRECCAR 07 cohort.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Centre Oscar Lambret
Lille, France
Centre Hospitalier Lyon-Sud
Lyon, France
Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes
Marseille, France
Hôpital La Timone, AP-HM
Marseille, France
CRLC Val d'Aurelle - Paul Lamarque
Montpellier, France
Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes
Nantes, France
CHU de Nimes
Nîmes, 30029, France
Hôpital Saint Antoine (AP-HP)
Paris, France
Hôpital Pontchaillou
Rennes, France
Hôpital Charles-Nicolle
Rouen, France
Hôpital Purpan - CHU de Toulouse
Toulouse, France
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Prudhomme, MD
CHU Nimes
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 24, 2020
Study Start
May 24, 2022
Primary Completion
May 1, 2025
Study Completion
May 1, 2026
Last Updated
June 25, 2024
Record last verified: 2024-06