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Recruiting NCT07316426

Preoptimisation in Ventral Hernia Surgery

No phase Interventional Hernia Hernia, Ventral Hernia Incisional Hernia, Umbilical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: preoptimisation programme.
Who it may be relevant to
Registry conditions: Hernia, Hernia, Ventral, Hernia Incisional, Hernia, Umbilical. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Preoptimisation in Ventral Hernia Surgery- a Randomised Trial

Overview

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.

Interventions

  • Procedure preoptimisation 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.

Primary outcome measures

  • Complications at three months postoperatively [Time frame: 3 months postoperatively]
Secondary outcome measures (12)
  • Complications at twelve months postoperatively [Time frame: 12 months postoperatively]
  • Patient-reported pain [Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.]
  • Quality of life with EQ-5D [Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.]
  • Aesthetic outcome [Time frame: Measured at clinical follow-upat 3 and 12 months postoperatively.]
  • Recurrence rate [Time frame: Measured at clinical follow-up at 3 and 12 months postoperatively.]
  • Change in physical activity [Time frame: meassured close to inclusion and within a few weeks preoperatively.]
  • Weight [Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.]
  • Collagen metabolism [Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.]
  • Hba1c [Time frame: at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.]
  • Hernia aperature width [Time frame: measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion]
  • B-PETH [Time frame: at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.]
  • Rutine labarotory tests [Time frame: At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Sweden · 5 centers
  • Gällivare hospital — Gällivare
  • Sunderby Hospital — Luleå
  • Lycksele Hospital — Lycksele
  • Skellefteå Hospital — Skellefteå
  • Umeå University Hospital — Umeå

Identifiers

NCT: NCT07316426 · PreOpt

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗