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Recruiting NCT06611462

STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair

Trial Parameters

Condition Ventral Hernia
Sponsor Bispebjerg Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-04
Completion 2026-03-01
Interventions
Prehabilitation (the STRONG programme)

Brief Summary

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.

Eligibility 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

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