Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04966065
Study type	Observational
Source	University Hospital, Ghent
Contact
Status	Terminated
Phase
Start date	March 14, 2016
Completion date	December 31, 2018

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See also
Status	Clinical Trial	Phase
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Completed	`NCT00908661` - Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia	N/A
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Terminated	`NCT00641342` - Prevention of Parastomal Hernia by Primary Mesh Insertion	Phase 2/Phase 3
Recruiting	`NCT04440514` - Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)
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Completed	`NCT01722565` - Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection	Phase 4
Completed	`NCT02368873` - the Use of a IPOM Mesh for Prevention of Parastomal Hernia	N/A
Completed	`NCT00917995` - Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh	Phase 2/Phase 3
Completed	`NCT02233465` - Treating Parastomal Hernia With a Mesh	Phase 1/Phase 2
Completed	`NCT01484743` - Risk Factors for Morbidity After Parastomal Hernia Repair
Completed	`NCT00509054` - Prevention of Parastomal Hernia With a Mesh	Phase 4
Completed	`NCT04187235` - Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies — PHARAO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms