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

NCT06611462 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-09-25

No results posted yet for this 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.

Conditions

  • Ventral Hernia
  • Surgery
  • Risk Reduction
  • Lifestyle
  • Postoperative Complications
  • Prehabilitation

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER
  • Zealand University Hospital

    collaborator OTHER
  • Holbaek Sygehus

    collaborator OTHER
  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Hanne Tønnesen, Professor MD · WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-03-01
Completion
2028-03-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611462 on ClinicalTrials.gov