Actively Recruiting
STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
Led by Bispebjerg Hospital · Updated on 2024-09-25
400
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
B
Bispebjerg Hospital
Lead Sponsor
C
Copenhagen University Hospital at Herlev
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older scheduled for ventral hernia repair with a defect smaller than 8 cm
- Enough time available for at least 4 weeks of prehabilitation before surgery
- Screened positive for at least one risky lifestyle factor among smoking, nutrition, alcohol intake, or physical inactivity (SNAP)
- Signed informed consent to participate
You will not qualify if you...
- Ventral hernia repairs with a defect larger than 8 cm
- Currently pregnant or breastfeeding
- Allergy or other contraindications to pharmaceutical or nutritional support
- Contraindications to exercise
- History of complicated alcohol withdrawal symptoms such as delirium or seizures
- Unable to participate in the intervention due to psychiatric illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Copenhagen University Hospital at Herlev
Herlev, Denmark, 2730
Actively Recruiting
2
Holbaek Sygehus
Holbæk, Denmark, 4300
Not Yet Recruiting
3
Zealand University Hospital
Køge, Denmark, 4600
Not Yet Recruiting
Research Team
H
Hanne Tønnesen, Professor MD
CONTACT
S
Sofie AS Jensen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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