Preoptimisation in Ventral Hernia Surgery (PreOpt)

Umeå University

Status: Enrolling

Conditions: Hernia Incisional; Hernia, Umbilical; Hernia; Hernia, Ventral

Treatments: Procedure: preoptimisation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT07316426

PreOpt

Details and patient eligibility

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption.

Treatment:

Procedure: preoptimisation programme

control

No Intervention group

Description:

The control group will receive basic guidance on physical activity and weight management during the preoperative consultation.