Intraperitoneal mesh placement
ProcedureMesh placement inside the peritoneal cavity.
NCT Number: NCT01543789
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
ASZ Aalst, Aalst, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mesh placement inside the peritoneal cavity.
Mesh placement between peritoneum and muscle layer.
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.
Time frame: Up to 1 year.
Time frame: up to 2 years
Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
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.
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.
University Hospital, Ghent
Other
The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.
Acronym: FUN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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