The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

Not Applicable

Completed

• Conditions: Umbilical Hernia
• Interventions: Procedure: Preperitoneal mesh placement; Procedure: Intraperitoneal mesh placement

• Registration Number: NCT01543789
• Lead Sponsor: University Hospital, Ghent

Brief Summary

The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery.

This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-10
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2015-12
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• written informed consent from the patient or his/her legal representative
• primary umbilical hernia requiring elective surgical repair
• diameter between 0 and 3 cm

Exclusion Criteria

• no written informed consent
• incisional hernia at the level of the umbilicus
• recurrent umbilical hernia, as they have to be considered an incisional hernia
• emergency surgery (incarcerated hernia)
• pregnancy
• non-compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preperitoneal mesh placement	Preperitoneal mesh placement	Mesh placement between peritoneum and muscle layer.
Intraperitoneal mesh placement	Intraperitoneal mesh placement	Mesh placement inside the peritoneal cavity

Primary Outcome Measures

Name	Time	Method
Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.	Total duration of the operation with an expected average of approximately 45 minutes.	Time registration of the operating time will be extracted from the hospital electronic patient files.

Secondary Outcome Measures

Name	Time	Method
Surgical wound morbidity complication rate.	Up to 1 year.
Recurrence Rate	up to 2 years	Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
Pain evaluation	within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years	A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has pain. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score.
Discomfort evaluation.	Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.	A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has discomfort. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score.

Trial Locations

Locations (3)

ASZ Aalst; 🇧🇪 Aalst, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium