RecruitingNot ApplicableNCT07316426

Preoptimisation in Ventral Hernia Surgery

Preoptimisation in Ventral Hernia Surgery- a Randomised Trial


Sponsor

Umeå University

Enrollment

130 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

PROCEDUREpreoptimisation 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

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NCT07316426


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