Status:
ACTIVE_NOT_RECRUITING
A Multicenter Belgian Trial of Ventral Hernia Repair (UNITE)
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Royal Belgian Society for Surgery
Archer Research
Conditions:
Ventral Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with incisional midline ventral hernias with a minimal width of 3 cm and a maximal width of 8 cm, treated according to the standard practice of the participating investigators. Patients can ...
Detailed Description
Ventral hernia repair 1. Laparoscopic: In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general step...
Eligibility Criteria
Inclusion
- Patient with incisional midline ventral hernia (M2: epigastric, M3: umbilical, M4: infra-umbilical) with a minimal width of 3 cm and a maximum width of 8 cm. Multiple hernia defects (Swiss cheese) are allowed according to European Hernia Society (EHS) classification (Appendix 1).
- Recurrences are only allowed to be included after former primary repair (suture repair without mesh).
- Patients with ASA grade I to III.
- Patient is at least 18 years old.
- Patient must sign and date the informed consent form prior to treatment.
- Patient is able to tolerate general anesthesia.
Exclusion
- Patient with a life expectancy of less than 2 years.
- Patient is suspected of being unable to comply with the study protocol.
- Patient is pregnant.
- Patient needs acute surgery.
- Patient is enrolled in another study.
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04437043
Start Date
December 16 2020
End Date
December 30 2024
Last Update
July 3 2024
Active Locations (1)
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1
Ghent University Hospital
Ghent, East Flanders, Belgium, 9000