Intensive lifestyle intervention for patients undergoing ventral hernia repair
Official title: Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)
Run by Bispebjerg Hospital · NCT06611462 · Data updated 2026-11-12
This study tests if a special program that helps people change unhealthy habits can reduce complications after surgery for ventral hernia repair.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 3 sites (Herlev and 2 other locations) |
| Status | Recruiting |
| Started | March 4, 2024 |
| Main results expected | March 1, 2026 |
| Study ends | March 1, 2028 |
| Registry record updated | September 25, 2024 |
| Trial ID | NCT06611462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for ventral hernia repair with a defect smaller than 8 cm and who exhibit at least one risky lifestyle factor.
✕Probably not a fit
Patients with larger hernia defects, those who are pregnant or breastfeeding, or individuals with contraindications to the intervention will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the impact of the STRONG programme, an intensive prehabilitation intervention, on patients scheduled for ventral hernia repair who exhibit risky lifestyles such as smoking, poor nutrition, excessive alcohol intake, and physical inactivity. Participants will be randomly assigned to either the STRONG programme or standard treatment, with the aim of reducing postoperative complications. The programme includes tailored education, motivational support, and pharmaceutical assistance, and participants will be monitored for health outcomes and costs over a two-year period. The hypothesis is that the STRONG programme will significantly reduce complication rates within 30 days post-surgery.
Why it matters
Potential benefit: If successful, this intervention could lead to fewer postoperative complications and improved recovery for patients undergoing ventral hernia repair.
How similar studies have gone: Other studies have shown success with lifestyle interventions in surgical patients, suggesting that this approach may be effective, although the specific combination of factors in this study is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants ≥18 years scheduled for ventral hernia repair (defect smaller than 8cm) * Enough time for at least 4 weeks of prehabilitation * Screened positive for at least 1 risky SNAP factor * Signed informed consent Exclusion Criteria: * Ventral hernia repairs with defect larger than 8 cm * Pregnancy/breastfeeding * Allergy/other contradiction to pharmaceutical and/or nutritional support * Contradiction to exercise * Previous complicated alcohol withdrawal symptoms (delirium or seizures) * Not able to participate in intervention due to psychiatric ilness
Where it's running
-
Copenhagen University Hospital at Herlev
Herlev, Denmark Recruiting -
Holbaek Sygehus
Holbæk, Denmark Not yet recruiting -
Zealand University Hospital
Køge, Denmark Not yet recruiting
Study contacts
- Principal investigator: Hanne Tønnesen, Professor MD — WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
- Study coordinator: Hanne Tønnesen, Professor MD
- Email: hanne.tonnesen@regionh.dk
- Phone: +4538163840
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.