Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Copenhagen University Hospital at Herlev
RECRUITING
Herlev
Holbaek Sygehus
NOT_YET_RECRUITING
Holbæk
Zealand University Hospital
NOT_YET_RECRUITING
Køge
Contact Information
Primary
Hanne Tønnesen, Professor MD
hanne.tonnesen@regionh.dk
+4538163840
Backup
Sofie AS Jensen, MD
sofie.anne-marie.skovbo.jensen.01@regionh.dk
Time Frame
Start Date:2024-03-04
Estimated Completion Date:2028-03-01
Participants
Target number of participants:400
Treatments
Experimental: Prehabilitation
Intervention (the STRONG programme): At least six counselling sessions (around one per week) prior to surgery as an integrated prehabilitation programme tailored to the individual patient's need for risk reduction at surgery based on a baseline screening for risky SNAP factors. It is delivered via the surgical Engage in the process of change. The smoking cessation intervention follows the Gold Standard Programme and a similar structure has been used for alcohol cessation, physical exercise, and nutrition interventions. All participants in the intervention group will receive immunonutrition in the days before surgery.
No_intervention: Treatment as usual
Treatment as usual in the preoperative period in the included hospital departments, e.g. brief counselling/advice regarding smoking cessation and weight loss, and handing out the national folders on smoking and surgery. Participants are free to access support to lifestyle changes in the community.