Evaluation of the Parietex TM Parastomal No Hole Mesh for... | NCT04966065

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

NCT04966065

Sponsor

University Hospital, Ghent

Status

Terminated

Last Update Posted

Sep 1, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Parastomal Hernia

Interventions

Parietex Parastomal mesh

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

too slow patiënts recruitment

Expanded Access Info

Start Date

Mar 14, 2016Actual

Primary Completion Date

Sep 24, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jul 7, 2021

First Submission Date that Met QC Criteria

Jul 7, 2021

First Posted Date

Jul 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2023

Last Update Posted Date

Sep 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, GhentOTHER

Collaborators

Name	Class
Algemeen Ziekenhuis Maria Middelares	OTHER
University of Wuerzburg	OTHER
Universitaire Ziekenhuizen KU Leuven	OTHER
Bispebjerg Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parietex Parastomal mesh	Device	Laparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Berrevoet, MD, PhD	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital		Ghent	East Flanders	9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided