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

Last updated: September 20, 2024
Sponsor: Bispebjerg Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Hernia

Pentalogy Of Cantrell

Treatment

Prehabilitation (the STRONG programme)

Clinical Study ID

NCT06611462
H-23028872
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

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

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Prehabilitation (the STRONG programme)
Phase:
Study Start date:
March 04, 2024
Estimated Completion Date:
March 01, 2028

Study 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.

Connect with a study center

  • Copenhagen University Hospital at Herlev

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Holbaek Sygehus

    Holbæk, 4300
    Denmark

    Site Not Available

  • Zealand University Hospital

    Køge, 4600
    Denmark

    Site Not Available

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