Clinical Trial: The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.

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 Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Surgical wound morbidity complication rate. [ Time Frame: Up to 1 year. ]
  • Recurrence Rate [ Time Frame: up to 2 years ]
    Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
  • Pain evaluation [ Time Frame: 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. [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: February 10, 2012
Date Started: March 2012
Date Completion: March 2016
Last Updated: June 2, 2015
Last Verified: June 2015