RecruitingNot ApplicableNCT06611462

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)

Sponsor

Bispebjerg Hospital

Enrollment

400 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Prehabilitation Postoperative Complications Risk Reduction Lifestyle Ventral Hernia

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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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Interventions

BEHAVIORALPrehabilitation (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.