STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
Recruiting · NCT06611462 · Interventional (participants receive a specific treatment) · Lead sponsor: Bispebjerg Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The five risky lifestyles Smoking, Nutrition (obesity and malnutrition), risky Alcohol intake, and Physical inactivity (SNAP) are common in surgical patients and associated with worse postoperative outcomes. Mono-factor interventions targeting and improving these risky lifestyles have been shown to reduce the risk at surgery, but there is a lack of systematic assessment of all five lifestyles of the patient before surgery and related optimization. This study aims to evaluate the effect of intensive combined lifestyle interventions (the STRONG programme) compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications, health, and costs on short and longer term. The hypothesis is that the STRONG programme will halve the complication rates within 30 days.
Who can take part
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 is running
3 locations listed.
- Copenhagen University Hospital at Herlev - Herlev, Denmark
- Holbaek Sygehus - Holbæk, Denmark
- Zealand University Hospital - Køge, Denmark