Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
- Conditions
- Parastomal Hernia
- Registration Number
- NCT04966065
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Short Title: PHARAOH study: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH A NO HOLE MESH.
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- adult patients, planned for primary elective laparoscopic hernia repair of an end-colostomy.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the QoL with the Stomy-QoL score assessment 24 months Evaluation of the QoL with the Stomy-QoL score assessment of patients preop, at 1 month, 12 months and 24 months postoperatively
- Secondary Outcome Measures
Name Time Method Recurrence rate 24 months Evaluation of the recurrence rates after surgical repair
Peri-operative complications 6 months All intra- and postoperative complications involving the surgical procedure
Trial Locations
- Locations (1)
Ghent University Hospital
🇧🇪Ghent, East Flanders, Belgium