Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
NCT ID: NCT04966065
Last Updated: 2023-09-01
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.
TERMINATED
10 participants
OBSERVATIONAL
2016-03-14
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objectives:
Evaluation of operative complications, colostomy function, Quality of Life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a ParietexTM Parastomal No Hole mesh.
Principle Investigators:
Prof. Dr. Frederik Berrevoet, University Hospital Ghent Dr. Filip Muysoms, AZ Maria Middelares Ghent
Patient selection:
Adult consecutive patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy. A logbook will be kept of adult patients undergoing a parastomal hernia repair in the participating centers during the study period that are not entered in the study, including the reason for non inclusion. A total of 100 patients will be included during 24 months or until the sample size has been reached.
Exclusion criteria: previous repair of a parastomal hernia at the same site, emergency operations, open parastomal hernia repair, parastomal hernias at an ileostomy or an ileal conduit stoma, loop colostomies, patients under the age of 18 years, pregnant women, ASA score 4 or more, no informed consent of the patient, patients unable to complete the stoma Quality of Life assessment.
Primary Endpoint:
Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.
Secondary Endpoints:
Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevention of Parastomal Hernia by Primary Mesh Insertion
NCT00641342
Role of Prosthetic Mesh in Preventing Parastomal Hernias
NCT01955278
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
NCT00917995
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
NCT01848184
Peristomal Mesh for Prophylaxis of Parastomal Hernia
NCT00496418
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.
Secondary Endpoints:
Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.
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.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Parietex Parastomal mesh
Laparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* emergency operations
* open parastomal hernia repair
* parastomal hernias at an ileostomy or an ileal conduit stoma
* loop colostomies
* patients under the age of 18 years
* pregnant women
* ASA score 4 or more
* no informed consent of the patient
* patients unable to complete the stoma Quality of Life assessment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Algemeen Ziekenhuis Maria Middelares
OTHER
University of Wuerzburg
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Bispebjerg Hospital
OTHER
University Hospital, Ghent
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.
Frederik Berrevoet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ghent University Hospital
Ghent, East Flanders, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015_0164
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.