STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
- Conditions
- Ventral HerniaSurgeryRisk ReductionLifestylePostoperative ComplicationsPrehabilitation
- Interventions
- Behavioral: Prehabilitation (the STRONG programme)
- Registration Number
- NCT06611462
- Lead Sponsor
- Bispebjerg Hospital
- Brief 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.
- Detailed Description
This study is a multicentre randomised controlled trial. A total of 400 participants with one or more of the five risky SNAP lifestyles will be randomised to either the STRONG programme (a prehabilitation intervention) or treatment as usual preoperatively (control). The STRONG programme is individually tailored to the needs of the participants. The program contains education, motivational, and pharmaceutical support. All participants will be followed up at the end of the intervention/at surgery, one, three, and six months after surgery. Long-term outcomes are followed up from national registers two years after surgery.
Interim analysis will be employed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- Ventral hernia repairs with defect larger than 8 cm
- Pregnancy/breastfeeding
- Allergy/other contradiction to pharmaceutical and/or nutritional support
- Contradiction to exercise
- Previous complicated alcohol withdrawal symptoms (delirium or seizures)
- Not able to participate in intervention due to psychiatric ilness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation Prehabilitation (the STRONG programme) 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.
- Primary Outcome Measures
Name Time Method Postoperative complications within 30 days 30 days Number and proportion of participants with at least one postoperative complication defined by requiring treatment
- Secondary Outcome Measures
Name Time Method Postoperative complications within 3 and 6 months 3 months, 6 months Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Comprehensive Complication Index (CCI) 30 days, 3 months, 6 months Calculated from the Clavien-Dindo classification of the postoperative complications
Successful quitting of risky lifestyles End of intervention/at surgery, 30 days, 3 months, 6 months Number and proportion of participants without all of their preoperative risky lifestyles (identified at baseline). Successful quitting of risky lifestyles are defined as:
* Smoking: no use of any tobacco products
* Malnutrition: not at risk of malnutrition defined as NRS \<3
* Obesity: 5-10 % loss of body fat mass compared to baseline
* Alcohol: Zero alcohol intake at end of intervention/surgery and below risky limits (\<14 units per week) at postoperative follow-ups
* Physical inactivity: being physically active at least 3.5 hours per weekAny improvement of risky lifestyles End of intervention/at surgery, 30 days, 3 months, 6 months Number and proportion of participants with any improvement of any of their risky lifestyles compared with baseline. Any improvements include:
* Smoking: a reduced number of cigarettes
* Malnutrition: improvement in level of malnutrition (NRS scale)
* Obesity: any loss of body fat mass
* Alcohol: a reduced alcohol intake weekly (reduced number of units weekly)
* Physical inactivity: Any improvement in minutes of daily physical activityHealth-Related Quality of Life (HRQoL) End of intervention/at surgery, 30 days, 3 months, 6 months Number and proportion of patients with improvement of HRQoL compared with baseline. HRQoL is measured by the EQ-5D instrument
Costs 30 days, 6 months, 2 years Measured as individual direct and indirect healthcare costs per patient based on data from national registries
Cost-effectiveness 2 years Calculated as a probability in percent (%)
Patient expectations Baseline Measured as a number on a VAS scale from 0-10
Patient reflections 1 Baseline Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle
Patient reflections 2 Baseline Qualitative analysis of patient reflections obtained from semi-structured interviews
Trial Locations
- Locations (3)
Copenhagen University Hospital at Herlev
🇩🇰Herlev, Denmark
Holbaek Sygehus
🇩🇰Holbæk, Denmark
Zealand University Hospital
🇩🇰Køge, Denmark