An interventional study of Intraperitoneal mesh placement and Preperitoneal mesh placement in Umbilical Hernia, sponsored by University Hospital, Ghent. Completed at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 44 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mesh placement inside the peritoneal cavity
Procedure: Intraperitoneal mesh placement
Mesh placement between peritoneum and muscle layer.
Procedure: Preperitoneal mesh placement
Mesh placement inside the peritoneal cavity.
Mesh placement between peritoneum and muscle layer.
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.
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.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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