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Preoptimisation in Ventral Hernia Surgery- a Randomised Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Gällivare hospital
RECRUITING
Gällivare
Sunderby Hospital
RECRUITING
Luleå
Lycksele Hospital
NOT_YET_RECRUITING
Lycksele
Skellefteå Hospital
NOT_YET_RECRUITING
Skellefteå
Umeå University Hospital
RECRUITING
Umeå
Contact Information
Primary
Gunnar Nordqvist, M.D.
gunnar.nordqvist@umu.se
+46768227094
Backup
Viktor Holmdahl, Phd
viktor.holmdahl@umu.se
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 130
Treatments
Experimental: Intervention
The intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption.
No_intervention: control
The control group will receive basic guidance on physical activity and weight management during the preoperative consultation.
Sponsors
Leads: Umeå University
Collaborators: Region Norrbotten, Region Västerbotten

This content was sourced from clinicaltrials.gov