Clinical trial NCT04966065: Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parastomal Hernia
Keywords: ostomy
hernia
parastomal
sugarbaker
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Algemeen Ziekenhuis Maria Middelares
name: University of Wuerzburg
name: Universitaire Ziekenhuizen KU Leuven
name: Bispebjerg Hospital
First posted: 2021-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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:

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.

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

Primary outcomes:
measure: Evaluation of the QoL with the Stomy-QoL score assessment
timeFrame: 24 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: 24 months
measure: Peri-operative complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
Study officials:
affiliation: Universitair Ziekenhuis Gent
name: Frederik Berrevoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: