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RECRUITINGINTERVENTIONAL

STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in 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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Prehabilitation (the STRONG programme)

Participants screened positive for one or more SNAP factors and randomised to the intervention group will receive an individualised plan for prehabilitation of their specific SNAP factors.

Locations (3)

Copenhagen University Hospital at Herlev
Herlev, Denmark
Holbaek Sygehus
Holbæk, Denmark
Zealand University Hospital
Køge, Denmark