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ACTIVE NOT RECRUITING
NCT04437043
NA

A Multicenter Belgian Trial of Ventral Hernia Repair (UNITE)

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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 be treated with the following ventral hernia repair approaches: * Laparoscopic ventral hernia repair with closure of the defect (IPOM+) * Open ventral hernia repair with closure of the defect (retromuscular repair) * Robotic ventral hernia repair with closure of the defect (retromuscular repair) To evaluate the total number of days spent in the hospital within a period of 90 days post-operative. This will be calculated by adding the hospital length of stay for initial surgery or index-procedure, length of stay for any additional readmission resulting from the surgery or re-interventions, and emergency room visits resulting from the surgery or Serious Adverse Event (SAE) related to the index-procedure. Secondary objectives: To assess the safety, performance and efficacy of laparoscopic, open and robotic ventral hernia repair.

Official title: A Multicenter Belgian Trial on Ventral Hernia Repair. UNITE Study Protocol Number: RB-UNITE-01

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-12-16

Completion Date

2024-12-30

Last Updated

2024-07-03

Healthy Volunteers

No

Conditions

Interventions

OTHER

quality of life questionnaires

pain will be recorded in rest and activity (VAS) and patients will complete the quality of life questionnaires (CCS, BIQ). Also, the intake of analgesic medication will be registered. A clinical examination is conducted to evaluate the occurrence of seroma and to evaluate recurrence, defined as a protrusion of the contents of the abdominal cavity or preperitoneal fat through the defect, which is no longer covered by the mesh.

Locations (1)

Ghent University Hospital

Ghent, East Flanders, Belgium