Status:

RECRUITING

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

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Colostomy Stoma

Parastomal Hernia

Eligibility:

All Genders

18+ years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 24 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2026

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT04282473

Start Date

May 24 2022

End Date

May 1 2026

Last Update

June 25 2024

Active Locations (16)

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Page 1 of 4 (16 locations)

1

L'Hôpital Jean Minjoz

Besançon, France

2

CHU de Bordeaux

Bordeaux, France

3

CHRU Clermont- Ferrand Hôtel -Dieu

Clermont-Ferrand, France

4

Hôpital Beaujon (AP-HP)

Clichy, France