The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

University Hospital, Ghent44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Umbilical Hernia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

ASZ Aalst

Aalst, Belgium

Ghent University Hospital

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.

Time registration of the operating time will be extracted from the hospital electronic patient files.

Time frame: Total duration of the operation with an expected average of approximately 45 minutes.

Secondary Outcomes

Surgical wound morbidity complication rate.

Time frame: Up to 1 year.

Recurrence Rate

Clinical examination will be performed. No ultrasound, unless doubt about recurrence.

Time frame: up to 2 years

Pain evaluation

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.

Time frame: within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years

Discomfort evaluation.

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.

Time frame: Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.