The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

Umbilical Hernia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543789
• Other study ID #: EC/2012/072
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Umbilical Hernia

Intervention

Procedure:
• Intraperitoneal mesh placement
Mesh placement inside the peritoneal cavity.
• Preperitoneal mesh placement
Mesh placement between peritoneum and muscle layer.

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	Ghent University Hospital	Ghent
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Medri

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Total duration of the operation with an expected average of approximately 45 minutes.
Secondary	Surgical wound morbidity complication rate.		Up to 1 year.
Secondary	Recurrence Rate	Clinical examination will be performed. No ultrasound, unless doubt about recurrence.	up to 2 years
Secondary	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.	within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years
Secondary	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.	Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.

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