Preoptimisation in Ventral Hernia Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • preoptimisation programme

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Umeå University

Lead sponsor

Region Norrbotten

Collaborator

Region Västerbotten

Collaborator