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

Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomieswith a Laparoscopic Modified Sugarbaker Technique in a Prospective Multicenter International Observational Study

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.

Study Overview

• Status: Terminated
• Conditions: Parastomal Hernia
• Intervention / Treatment: Device: Parietex Parastomal mesh

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Belgium
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Evaluation of the recurrence rates after surgical repair	24 months
Peri-operative complications	All intra- and postoperative complications involving the surgical procedure	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Bispebjerg Hospital; Algemeen Ziekenhuis Maria Middelares; University of Wuerzburg
• Investigators: Principal Investigator: Frederik Berrevoet, MD, PhD, Universitair Ziekenhuis Gent

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2016
• Primary Completion (Actual): September 24, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: hernia; ostomy; parastomal; sugarbaker
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 2015_0164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No