Preoptimisation in Ventral Hernia Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
preoptimisation programme
Procedure/SurgeryThe 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Complications at three months postoperatively
Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.
Time frame
3 months postoperativelySecondary outcomes
1
Complications at twelve months postoperatively
Incidence of surgical and medical complications at 12 months postoperatively.
Time frame
12 months postoperatively2
Patient-reported pain
Patient-reported pain measured with Ventral Hernia Pain Questionnaire, VHPQ. Max score is 40 and minimum score is 0, a lower score indicates less abdominal wall pain.
Time frame
Measured at inclusion, preoperatively, 3 and 12 months postoperatively.3
Quality of life with EQ-5D
Quality of life assessed using the EuroQol 5-Dimensions questionnaire (EQ-5D index score). Max score is 1.0, which equals to perfect health and a lower score indicates lower quality of life with 0 is equivalent to death. Negative scores indicated health states considered worse than dead (e.g. severe disability).
Time frame
Measured at inclusion, preoperatively, 3 and 12 months postoperatively.4
Aesthetic outcome
Patient reported aestethic outcome measured with a Numerical Ratin Scale, NRS scale, range 1-10 where a higher score indicates better patient reported aesthetic outcome.
Time frame
Measured at clinical follow-upat 3 and 12 months postoperatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov