Pre‑surgery optimisation for ventral hernia repair
Preoptimisation in Ventral Hernia Surgery- a Randomised Trial
NA · Umeå University · NCT07316426
This trial tests whether a structured pre-surgery programme to boost activity, encourage weight loss, and optimise other health problems helps adults with 4–8 cm ventral hernias have fewer complications after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University (other) |
| Locations | 5 sites (Gällivare, Norrbotten County and 4 other locations) |
| Trial ID | NCT07316426 on ClinicalTrials.gov |
What this trial studies
This is a multicentre, single-blinded, randomised trial that assigns adults with a 4–8 cm ventral hernia defect to either a multimodal preoptimisation programme or to usual care with surgery without structured preoptimisation. The preoptimisation programme includes interventions to increase physical activity, promote weight loss, and optimise treatment of comorbidities before elective repair. The primary outcome is postoperative complications measured at three months. During surgery the team will collect skin, muscle, and fascia biopsies and take blood samples before and after surgery to study molecular effects, especially on collagen metabolism.
Who should consider this trial
Good fit: Adults (≥18 years) with a symptomatic ventral hernia and a defect width of at least 4 cm who are scheduled for elective repair and able to consent and participate in a pre-surgery programme.
Not a fit: Patients needing emergency hernia surgery, those with very limited physical function or expected survival under three years, or those unable to follow the preoptimisation activities are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the programme could lower postoperative complication rates and improve wound healing and recovery for patients undergoing ventral hernia repair.
How similar studies have performed: Prehabilitation programmes for abdominal surgery have shown mixed but promising results for reducing complications, while multimodal preoptimisation specifically for ventral/incisional hernia is relatively novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gällivare, Norrbotten County and 4 other locations
- Gällivare hospital — Gällivare, Norrbotten County, Sweden (RECRUITING)
- Sunderby Hospital — Luleå, Norrbotten County, Sweden (RECRUITING)
- Lycksele Hospital — Lycksele, Västerbotten County, Sweden (NOT_YET_RECRUITING)
- Skellefteå Hospital — Skellefteå, Västerbotten County, Sweden (NOT_YET_RECRUITING)
- Umeå University Hospital — Umeå, Västerbotten County, Sweden (RECRUITING)
Study contacts
- Study coordinator: Gunnar Nordqvist, M.D.
- Email: gunnar.nordqvist@umu.se
- Phone: +46768227094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hernia, Hernia, Ventral, Hernia Incisional, Hernia, Umbilical, preoptimisation, prehabilitation