Clinical trial NCT04282473: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Official title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colostomy Stoma
Parastomal Hernia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients included in the GRECCAR 07 cohort.

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 without mesh placement.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of parastomal hernia between groups
timeFrame: 5 years after colostomy formation
measure: Date of parastomal hernia
timeFrame: 5 years after colostomy formation
Secondary outcomes:
measure: Protrusion around the stoma
timeFrame: 5 years after colostomy formation
measure: Patient reported pain
timeFrame: 5 years after colostomy formation
measure: Occlusion
timeFrame: 5 years after colostomy formation
measure: Incarceration
timeFrame: 5 years after colostomy formation
measure: Patient reported quality of life
timeFrame: 5 years after colostomy formation
measure: Pain at colostomy site
timeFrame: 5 years after colostomy formation
measure: Discomfort
timeFrame: 5 years after colostomy formation
measure: Patient reported satisfaction
timeFrame: 5 years after colostomy formation
measure: Number of specialist and general consultations attended by patients between groups
timeFrame: 5 years after colostomy formation
measure: Number of medications taken in each group
timeFrame: 5 years after colostomy formation
measure: Other associated treatment received by patients in each group
timeFrame: 5 years after colostomy formation
measure: Rehabilitation sessions undergone by patients in each group
timeFrame: 5 years after colostomy formation
measure: Sick leave taken by patients in each group
timeFrame: 5 years after colostomy formation
measure: Cost of patients care
timeFrame: 5 years after colostomy formation
Other outcomes:
Locations:
city: Besançon
country: France
facility: L'Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: CHRU Clermont- Ferrand Hôtel -Dieu
city: Clichy
country: France
facility: Hôpital Beaujon (AP-HP)
city: Grenoble
country: France
facility: Hôpital Albert Michallon
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Marseille
country: France
facility: Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes
city: Marseille
country: France
facility: Hôpital La Timone, AP-HM
city: Montpellier
country: France
facility: CRLC Val d'Aurelle - Paul Lamarque
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hôpital Saint Antoine (AP-HP)
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles-Nicolle
city: Toulouse
country: France
facility: Hôpital Purpan - CHU de Toulouse
Study officials:
affiliation: CHU Nimes
name: Michel Prudhomme, MD
role: PRINCIPAL_INVESTIGATOR
References: