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

NCT04966065 | Terminated

• 1 other identifier: 2015_0164
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parastomal Hernia

Keywords

ostomy; hernia; parastomal; sugarbaker

Outcome Measures

Primary Outcomes (1)

• Evaluation of the QoL with the Stomy-QoL score assessment

  Evaluation of the QoL with the Stomy-QoL score assessment of patients preop, at 1 month, 12 months and 24 months postoperatively

  24 months

Secondary Outcomes (2)

• Recurrence rate

  24 months

• Peri-operative complications

  6 months

Interventions

Parietex Parastomal mesh DEVICE

Laparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 adult patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy.

You may qualify if:

• \- adult patients, planned for primary elective laparoscopic hernia repair of an end-colostomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Algemeen Ziekenhuis Maria Middelares: collaborator
• University of Wuerzburg: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Bispebjerg Hospital: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederik Berrevoet, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 19, 2021
• Study Start: March 14, 2016
• Primary Completion: September 24, 2018
• Study Completion: December 31, 2018
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)