STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
NCT06611462 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-09-25
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.
Conditions
- Ventral Hernia
- Surgery
- Risk Reduction
- Lifestyle
- Postoperative Complications
- Prehabilitation
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.
Sponsors & Collaborators
-
Copenhagen University Hospital at Herlev
collaborator OTHER -
Zealand University Hospital
collaborator OTHER -
Holbaek Sygehus
collaborator OTHER -
Bispebjerg Hospital
lead OTHER
Principal Investigators
-
Hanne Tønnesen, Professor MD · WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-04
- Primary Completion
- 2026-03-01
- Completion
- 2028-03-01
Countries
- Denmark
Study Locations
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