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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Colostomy Stoma; Parastomal Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT04282473

NIMAO/2018-02/MP-01

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

134 participants in 2 patient groups

with mesh

Description:

Placement of lightweight (\<50g/m2) monofilament mesh during colostomy formation

no mesh

Description:

colostomy without mesh placement