Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07316426

Preoptimisation in Ventral Hernia Surgery

Led by Umeå University · Updated on 2026-01-05

130

Participants Needed

5

Research Sites

205 weeks

Total Duration

On this page

Sponsors

U

Umeå University

Lead Sponsor

R

Region Norrbotten

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Preoptimisation in Ventral Hernia Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 65 18 years.
Not Eligible

You will not qualify if you...

  • 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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Trial Site Locations

Total: 5 locations

1

Gällivare hospital

Gällivare, Norrbotten County, Sweden, 98238

Actively Recruiting

2

Sunderby Hospital

Luleå, Norrbotten County, Sweden, 94542

Actively Recruiting

3

Lycksele Hospital

Lycksele, Västerbotten County, Sweden, 92137

Not Yet Recruiting

4

Skellefteå Hospital

Skellefteå, Västerbotten County, Sweden, 93141

Not Yet Recruiting

5

Umeå University Hospital

Umeå, Västerbotten County, Sweden

Actively Recruiting

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Research Team

G

Gunnar Nordqvist, M.D.

CONTACT

V

Viktor Holmdahl, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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