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RECRUITING
NCT07316426
NA

Preoptimisation in Ventral Hernia Surgery

Sponsor: Umeå University

View on ClinicalTrials.gov

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.

Official title: Preoptimisation in Ventral Hernia Surgery- a Randomised Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-09-22

Completion Date

2029-09-01

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

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.

Locations (5)

Gällivare hospital

Gällivare, Norrbotten County, Sweden

Sunderby Hospital

Luleå, Norrbotten County, Sweden

Lycksele Hospital

Lycksele, Västerbotten County, Sweden

Skellefteå Hospital

Skellefteå, Västerbotten County, Sweden

Umeå University Hospital

Umeå, Västerbotten County, Sweden