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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Prehabilitation (the STRONG programme)
BehavioralParticipants 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: PrehabilitationExperimental treatment 1 intervention
Group B: Treatment as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Postoperative complications within 30 days
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Time frame
30 daysSecondary outcomes
1
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 months2
Comprehensive Complication Index (CCI)
Calculated from the Clavien-Dindo classification of the postoperative complications
Time frame
30 days, 3 months, 6 months3
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 months4
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 monthsOther outcomes
1
Postoperative length of stay
Descriptively reported as total time in hospital within 30 postoperative days with 95% CI
Time frame
From surgery until 30 days postoperative2
Readmission
Descriptively reported as number and proportion (in %) of participants with readmission with 95% CI
Time frame
90 days3
Time back to work/usual activities
Descriptively reported, patient reported
Time frame
30 days, 3 months, 6 months4
Hernia recurrence
Descriptively reported as number and proportion of participants with hernia recurrence
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bispebjerg Hospital
Lead sponsor
Copenhagen University Hospital at Herlev
Collaborator
Zealand University Hospital
Collaborator
Holbaek Sygehus
Collaborator
Source ClinicalTrials.gov