Actively Recruiting

Age: 18Years +
All Genders
ID04282473

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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