Actively Recruiting
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex 10 TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-06-25
134
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating long-term outcomes in patients who underwent a terminal colostomy, comparing those who had a lightweight monofilament mesh placed during the procedure with those who did not. This observational study follows participants from the GRECCAR 07 cohort to observe the rate of parastomal hernia and other related complications five years after colostomy formation. The study involves two groups: one with mesh placement during colostomy formation and one without mesh. The mesh used is a lightweight (less than 50g/m2) monofilament prosthesis called Parietex TCM. The study tracks outcomes five years post-surgery to assess the impact of mesh on hernia development and patient well-being. Participants will be assessed five years after their colostomy surgery for the presence and timing of parastomal hernia. Additional evaluations include patient-reported pain, protrusion around the stoma, occlusion, incarceration, quality of life, satisfaction, and healthcare usage such as consultations, medications, treatments, rehabilitation, sick leave, and cost of care. These measures provide a comprehensive view of long-term patient outcomes and safety.
CONDITIONS
Brief Title
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient must be affiliated with a health insurance programme
- Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N6 RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
- Patient received colostomy 5 years ago
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 years
Participants who underwent colostomy 5 years ago with or without mesh placement are observed to assess the rate of parastomal hernia and related outcomes.
Periodic visits over 5 years depending on individual follow-up schedules
Trial Site Locations
Total: 16 locations
1
L'Hôpital Jean Minjoz
Besançon, France
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
3
CHRU Clermont- Ferrand Hôtel -Dieu
Clermont-Ferrand, France
Actively Recruiting
4
Hôpital Beaujon (AP-HP)
Clichy, France
Not Yet Recruiting
5
Hôpital Albert Michallon
Grenoble, France
Not Yet Recruiting
6
Centre Oscar Lambret
Lille, France
Actively Recruiting
7
Centre Hospitalier Lyon-Sud
Lyon, France
Actively Recruiting
8
Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes
Marseille, France
Not Yet Recruiting
9
Hôpital La Timone, AP-HM
Marseille, France
Not Yet Recruiting
10
CRLC Val d'Aurelle - Paul Lamarque
Montpellier, France
Not Yet Recruiting
11
Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes
Nantes, France
Actively Recruiting
12
CHU de Nimes
Nîmes, France, 30029
Actively Recruiting
13
Hôpital Saint Antoine (AP-HP)
Paris, France
Not Yet Recruiting
14
Hôpital Pontchaillou
Rennes, France
Not Yet Recruiting
15
Hôpital Charles-Nicolle
Rouen, France
Actively Recruiting
16
Hôpital Purpan - CHU de Toulouse
Toulouse, France
Actively Recruiting
Research Team
M
Michel Prudhomme, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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