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

Parastomal Hernia Clinical Trial

— PHARAO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04966065
• Other study ID #: 2015_0164
• Status: Terminated
• Start date: March 14, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: September 24, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Device:
• Parietex Parastomal mesh
Laparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East Flanders

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Ghent	Algemeen Ziekenhuis Maria Middelares, Bispebjerg Hospital, Universitaire Ziekenhuizen KU Leuven, University of Wuerzburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence rate	Evaluation of the recurrence rates after surgical repair	24 months
Secondary	Peri-operative complications	All intra- and postoperative complications involving the surgical procedure	6 months