NCT07316426 Preoptimisation in Ventral Hernia Surgery
| NCT ID | NCT07316426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2027-09-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and optimise the treatment of comorbidities, or to surgery without structured preoptimisation. The primary endpoint is complications at three months postoperatively. During surgery, biopsies of skin, muscle, and fascia will be collected, along with pre- and postoperative blood samples, to analyse the molecular effects of preoptimisation, particularly in relation to collagen metabolism.
Eligibility Criteria
Inclusion Criteria: * Patients with a ventral hernia with a defect width of at least 4 cm. * Symptom burden related to the hernia sufficient to justify surgical intervention. * Age ≥ 18 years. Exclusion Criteria: * Expected survival of less than three years. * Inability to comprehend oral and written information or to provide informed consent. * Acute complication of the hernia requiring emergency surgical intervention. * General condition characterised by severe limitations in physical functional capacity.