NCT07316426

Preoptimisation in Ventral Hernia Surgery

Preoptimisation in Ventral Hernia Surgery- a Randomised Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hernia
• Hernia, Ventral
• Hernia Incisional
• Hernia, Umbilical

Interventions

Type	Name	Description
PROCEDURE	preoptimisation programme	The intervention group follows a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use. Designed to suit both rural and urban populations in northern Sweden, the programme lasts for a minimum of three months before surgery.

Timeline

• Start date: 2025-09-22
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

5 sites across 1 country: Sweden