Intensive lifestyle intervention for patients undergoing ventral hernia repair
Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)
This study tests if a special program that helps people change unhealthy habits can reduce complications after surgery for ventral hernia repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 3 sites (Herlev and 2 other locations) |
| Trial ID | NCT06611462 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Herlev and 2 other locations
- 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
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.