STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBispebjerg Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Ventral hernia repairs with defect larger than 8 cm
Pregnancy/breastfeeding
Allergy/other contradiction to pharmaceutical and/or nutritional support
Contradiction to exercise
Trial design
Treatments tested in this trial
- Prehabilitation (the STRONG programme)
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Bispebjerg Hospital
Lead sponsor
Copenhagen University Hospital at Herlev
Collaborator
Zealand University Hospital
Collaborator
Holbaek Sygehus
Collaborator
Source ClinicalTrials.gov