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

Parastomal Hernia Clinical Trial

— RESEDAE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282473
• Other study ID #: NIMAO/2018-02/MP-01
• Status: Recruiting
• Start date: May 24, 2022
• Est. completion date: May 2024

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Michel Prudhomme, MD
• Phone: 06.43.50.35.22
• Email: michel.prudhomme[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 without mesh placement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colostomy Stoma
• Hernia
• Parastomal Hernia

Locations

Country	Name	City	State
France	L'Hôpital Jean Minjoz	Besançon
France	CHU de Bordeaux	Bordeaux
France	CHRU Clermont- Ferrand Hôtel -Dieu	Clermont-Ferrand
France	Hôpital Beaujon (AP-HP)	Clichy
France	Hôpital Albert Michallon	Grenoble
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier Lyon-Sud	Lyon
France	Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes	Marseille
France	Hôpital La Timone, AP-HM	Marseille
France	CRLC Val d'Aurelle - Paul Lamarque	Montpellier
France	Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes	Nantes
France	CHU de Nimes	Nîmes
France	Hôpital Saint Antoine (AP-HP)	Paris
France	Hôpital Pontchaillou	Rennes
France	Hôpital Charles-Nicolle	Rouen
France	Hôpital Purpan - CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of parastomal hernia between groups	Percentage patients with parastomal hernia taken from patient medical records	5 years after colostomy formation
Primary	Date of parastomal hernia	Date of parastomal hernia taken from patient records	5 years after colostomy formation
Secondary	Protrusion around the stoma	Yes/no	5 years after colostomy formation
Secondary	Patient reported pain	Yes/no	5 years after colostomy formation
Secondary	Occlusion	Yes/no	5 years after colostomy formation
Secondary	Incarceration	Yes/no	5 years after colostomy formation
Secondary	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
Secondary	Pain at colostomy site	0-100 scale (no pain to intolerable pain)	5 years after colostomy formation
Secondary	Discomfort	0-100 scale (very uncomfortable to very comfortable)	5 years after colostomy formation
Secondary	Patient reported satisfaction	0-100 scale (not at all satisfied to very satisfied)	5 years after colostomy formation
Secondary	Number of specialist and general consultations attended by patients between groups	number of consultations	5 years after colostomy formation
Secondary	Number of medications taken in each group	Number of medications taken	5 years after colostomy formation
Secondary	Other associated treatment received by patients in each group	number of treatments received	5 years after colostomy formation
Secondary	Rehabilitation sessions undergone by patients in each group	number of rehabilitation sessions	5 years after colostomy formation
Secondary	Sick leave taken by patients in each group	Number of days	5 years after colostomy formation
Secondary	Cost of patients care	Euros	5 years after colostomy formation