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RECRUITING
NCT06611462
NA

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

Sponsor: Bispebjerg Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-03-04

Completion Date

2028-03-01

Last Updated

2024-09-25

Healthy Volunteers

No

Interventions

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