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Clinical Trials in Denmark / NCT06611462
Recruiting Not applicable

STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair

NCT06611462 · tracked via the Priya Life Science Denmark tracker
Sponsor
Bispebjerg Hospital
Phase
Not applicable
Started
2024-03-04
Last updated
2024-09-25

Condition(s) studied

Ventral HerniaSurgeryRisk ReductionLifestylePostoperative ComplicationsPrehabilitation

Investigational drug(s) / intervention(s)

Prehabilitation (the STRONG programme)

Prehabilitation (the STRONG programme): 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Postoperative complications within 30 days — 30 days
    Number and proportion of participants with at least one postoperative complication defined by requiring treatment

Trial sites (3)

FacilityCityRegionStatus
Copenhagen University Hospital at Herlev Herlev Denmark Recruiting
Holbaek Sygehus Holbæk Denmark Not Yet Recruiting
Zealand University Hospital Køge Denmark Not Yet Recruiting

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A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure Enrolling by invitation

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The Nordic Rectal Prolapse Study Enrolling by invitation
CABGpreHAB - a Feasibility Study Protocol Recruiting
Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease Recruiting
Patients' Expectations Before Spinal Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06611462 on ClinicalTrials.gov ↗ ← All trials in Denmark