NCT06611462Recruiting
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 13 Feb 2024
- Start date
- 4 Mar 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Bispebjerg Hospital
- Diseases
- Obesity
- NCT number
- NCT06611462
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 4 Mar 2024 to the primary completion date, 1 Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous complicated alcohol withdrawal symptoms (delirium or seizures)
Other illness
- Allergy/other contradiction to pharmaceutical and/or nutritional support
- Not able to participate in intervention due to psychiatric ilness
Other
- Ventral hernia repairs with defect larger than 8 cm
- Pregnancy/breastfeeding
- Contradiction to exercise
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Copenhagen University Hospital at Herlev Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Holbaek Sygehus Coordinator of this site? Confirm its status | Holbæk | Denmark | Not yet recruiting |
| Zealand University Hospital Coordinator of this site? Confirm its status | Køge | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.