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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
Participants screened positive for one or more SNAP factors and randomised to the intervention group will receive an individualised plan for prehabilitation of their specific SNAP factors.
Copenhagen University Hospital at Herlev
Herlev, Denmark
RECRUITINGHolbaek Sygehus
Holbæk, Denmark
NOT_YET_RECRUITINGZealand University Hospital
Køge, Denmark
NOT_YET_RECRUITINGPostoperative complications within 30 days
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Time frame: 30 days
Postoperative complications within 3 and 6 months
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Time frame: 3 months, 6 months
Comprehensive Complication Index (CCI)
Calculated from the Clavien-Dindo classification of the postoperative complications
Time frame: 30 days, 3 months, 6 months
Successful quitting of risky lifestyles
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 week
Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months
Any improvement of risky lifestyles
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 activity
Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months
Health-Related Quality of Life (HRQoL)
Number and proportion of patients with improvement of HRQoL compared with baseline. HRQoL is measured by the EQ-5D instrument
Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months
Costs
Measured as individual direct and indirect healthcare costs per patient based on data from national registries
Time frame: 30 days, 6 months, 2 years
Cost-effectiveness
Calculated as a probability in percent (%)
Time frame: 2 years
Patient expectations
Measured as a number on a VAS scale from 0-10
Time frame: Baseline
Patient reflections 1
Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle
Time frame: Baseline
Patient reflections 2
Qualitative analysis of patient reflections obtained from semi-structured interviews
Time frame: Baseline
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