Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
NCT ID: NCT04282473
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
134 participants
OBSERVATIONAL
2022-05-24
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Primary Prevention of Peristomial Hernias Via Parietal Prostheses
NCT01380860
Hernia Prevention in Stomas
NCT00907842
Prevention of Parastomal Hernia by Primary Mesh Insertion
NCT00641342
Role of Prosthetic Mesh in Preventing Parastomal Hernias
NCT01955278
Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy
NCT02121743
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
with mesh
Placement of lightweight (\<50g/m2) monofilament mesh during colostomy formation
No interventions assigned to this group
no mesh
colostomy without mesh placement
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 signals opposition to participating in the study
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michel Prudhomme, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Nimes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIMAO/2018-02/MP-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.