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Clinical Trials in Sweden / NCT07316426
Recruiting Not applicable

Preoptimisation in Ventral Hernia Surgery

NCT07316426 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-09-22
Last updated
2026-01-05

Condition(s) studied

HerniaHernia, VentralHernia IncisionalHernia, Umbilical

Investigational drug(s) / intervention(s)

preoptimisation programme

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Gällivare hospital Gällivare Norrbotten County Recruiting
Sunderby Hospital Luleå Norrbotten County Recruiting
Lycksele Hospital Lycksele Västerbotten County Not Yet Recruiting
Skellefteå Hospital Skellefteå Västerbotten County Not Yet Recruiting
Umeå University Hospital Umeå Västerbotten County Recruiting

More Umeå University trials in Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07316426 on ClinicalTrials.gov ↗ ← All trials in Sweden