Clinical trial NCT06611462: STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
Official title: Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Surgery
Risk Reduction
Lifestyle
Postoperative Complications
Prehabilitation
Keywords: Ventral Hernia
Surgery
Risk Reduction
Postoperative Complications
Prehabilitation
Smoking
Alcohol drinking
Obesity
Malnutrition
Physical Inactivity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital at Herlev
name: Zealand University Hospital
name: Holbaek Sygehus
First posted: 2024-09-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised parallel design using block randomisation. Stratification for centre and number of SNAP factors (one, two, or ≥ 3).
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative complications within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative complications within 3 and 6 months
timeFrame: 3 months, 6 months
measure: Comprehensive Complication Index (CCI)
timeFrame: 30 days, 3 months, 6 months
measure: Successful quitting of risky lifestyles
timeFrame: End of intervention/at surgery, 30 days, 3 months, 6 months
measure: Any improvement of risky lifestyles
timeFrame: End of intervention/at surgery, 30 days, 3 months, 6 months
measure: Health-Related Quality of Life (HRQoL)
timeFrame: End of intervention/at surgery, 30 days, 3 months, 6 months
measure: Costs
timeFrame: 30 days, 6 months, 2 years
measure: Cost-effectiveness
timeFrame: 2 years
measure: Patient expectations
timeFrame: Baseline
measure: Patient reflections 1
timeFrame: Baseline
measure: Patient reflections 2
timeFrame: Baseline
Other outcomes:
measure: Postoperative length of stay
timeFrame: From surgery until 30 days postoperative
measure: Readmission
timeFrame: 90 days
measure: Time back to work/usual activities
timeFrame: 30 days, 3 months, 6 months
measure: Hernia recurrence
timeFrame: 90 days
measure: Reoperation for hernia recurrence
timeFrame: 90 days
measure: Visits to primary care
timeFrame: 30 days
measure: Successful quitting of risky lifestyles individually
timeFrame: End of intervention/at surgery, 30 days, 3 months, 6 months
measure: Change in ASA score
timeFrame: End of intervention/at surgery, 30 days, 3 months, 6 months
measure: Change of frailty
timeFrame: End of intervention/at surgery, 30 days, 3 months, 6 months
measure: Morbidity
timeFrame: 2 years
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital at Herlev
city: Holbæk
country: Denmark
facility: Holbaek Sygehus
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
name: Hanne Tønnesen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: