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

Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

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.

Study Overview

• Status: Recruiting
• Conditions: Parastomal Hernia; Colostomy Stoma

• Study Type: Observational
• Enrollment (Anticipated): 134

Contacts and Locations

• Study Contact: Name: Michel Prudhomme, MD; Phone Number: 06.43.50.35.22; Email: michel.prudhomme@chu-nimes.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • L'Hôpital Jean Minjoz
    • Contact: Zaher Lakkis; Phone Number: 03 81 66 71 73; Email: zlakkis@chu-besancon.fr
  • Bordeaux, France
    • Not yet recruiting
    • CHU de Bordeaux
  • Clermont-Ferrand, France
    • Recruiting
    • CHRU Clermont- Ferrand Hôtel -Dieu
    • Contact: Denis Pezet; Phone Number: 04 73 75 04 94; Email: dpezet@chu-clermontferrand.fr
  • Clichy, France
    • Not yet recruiting
    • Hôpital Beaujon (AP-HP)
    • Contact: Yves Panis; Phone Number: 01 40 87 45 47; Email: yves.panis@bjn.aphp.fr
    • Principal Investigator: Yves Panis
  • Grenoble, France
    • Not yet recruiting
    • Hôpital Albert Michallon
    • Contact: Jean-Luc Faucheron; Phone Number: 04 76 76 55 26; Email: JLFaucheron@chu-grenoble.fr
    • Principal Investigator: Jean-Luc Faucheron
  • Lille, France
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Mehrdad Jafari; Phone Number: 03 20 29 59 20; Email: m-jafari@o-lambret.fr
  • Lyon, France
    • Recruiting
    • Centre Hospitalier Lyon-Sud
    • Contact: Eddy Cotte; Phone Number: 04 78 86 18 01; Email: eddy.cotte@chu-lyon.fr
  • Marseille, France
    • Not yet recruiting
    • Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes
    • Contact: Bernard Lelong; Phone Number: 04 91 22 37 00; Email: lelongb@ipc.unicancer.fr
    • Principal Investigator: Bernard Lelong
  • Marseille, France
    • Not yet recruiting
    • Hôpital La Timone, AP-HM
    • Contact: Julie Duclos; Phone Number: 04 91 38 58 52; Email: julie.duclos@ap-hm.fr
    • Principal Investigator: Julie Duclos
  • Montpellier, France
    • Not yet recruiting
    • CRLC Val d'Aurelle - Paul Lamarque
    • Contact: Philippe Rouanet; Phone Number: 04 67 61 31 14; Email: philippe.rouanet@montpellier.unicancer.fr
    • Principal Investigator: Philippe Rouanet
  • Nantes, France
    • Recruiting
    • Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes
    • Contact: Guillaume Meurette; Phone Number: 02 40 08 30 22; Email: guillaume.meurette@chu-nantes.fr
    • Principal Investigator: Guillaume Meurette
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nimes
    • Principal Investigator: Michel Prudhomme
  • Paris, France
    • Not yet recruiting
    • Hôpital Saint Antoine (AP-HP)
    • Contact: Yann Parc; Phone Number: 01 49 28 25 47; Email: yann.parc@sat.aphp.fr
    • Principal Investigator: Yann Parc
  • Rennes, France
    • Not yet recruiting
    • Hôpital Pontchaillou
    • Contact: Bernard Meunier; Phone Number: 02 99 28 42 65; Email: bernard.meunier@chu-rennes.fr
    • Principal Investigator: Bernard Meunier
  • Rouen, France
    • Recruiting
    • Hôpital Charles-Nicolle
    • Contact: Jean-Jacques Tuech; Phone Number: 02 32 88 85 72; Email: jean-jacques.tuech@univ-rouen.fr
  • Toulouse, France
    • Recruiting
    • Hôpital Purpan - CHU de Toulouse
    • Contact: Guillaume Portier; Phone Number: 05 61 77 25 30; Email: portier.g@chu-toulouse.fr
    • Principal Investigator: Guillaume Portier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients included in the GRECCAR 07 cohort.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
with mesh; Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation
no mesh; colostomy without mesh placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protrusion around the stoma	Yes/no	5 years after colostomy formation
Patient reported pain	Yes/no	5 years after colostomy formation
Occlusion	Yes/no	5 years after colostomy formation
Incarceration	Yes/no	5 years after colostomy formation
Patient reported quality of life	Stoma-QoL questionnaire - a 20-item questionnaire on a four-point Likert scale with total score ranging from 0 (worst score) to 100 (best score)	5 years after colostomy formation
Pain at colostomy site	0-100 scale (no pain to intolerable pain)	5 years after colostomy formation
Discomfort	0-100 scale (very uncomfortable to very comfortable)	5 years after colostomy formation
Patient reported satisfaction	0-100 scale (not at all satisfied to very satisfied)	5 years after colostomy formation
Number of specialist and general consultations attended by patients between groups	number of consultations	5 years after colostomy formation
Number of medications taken in each group	Number of medications taken	5 years after colostomy formation
Other associated treatment received by patients in each group	number of treatments received	5 years after colostomy formation
Rehabilitation sessions undergone by patients in each group	number of rehabilitation sessions	5 years after colostomy formation
Sick leave taken by patients in each group	Number of days	5 years after colostomy formation
Cost of patients care	Euros	5 years after colostomy formation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Michel Prudhomme, MD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: NIMAO/2018-02/MP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No