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

Bispebjerg Hospital

Status: Enrolling

Conditions: Postoperative Complications; Lifestyle; Surgery; Ventral Hernia; Risk Reduction; Prehabilitation

Treatments: Behavioral: Prehabilitation (the STRONG programme)

Study type: Interventional

Funder types: Other

Identifiers

NCT06611462

H-23028872

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

Intervention (the STRONG programme): At least six counselling sessions (around one per week) prior to surgery as an integrated prehabilitation programme tailored to the individual patient's need for risk reduction at surgery based on a baseline screening for risky SNAP factors. It is delivered via the surgical "Engage in the process of change". The smoking cessation intervention follows the Gold Standard Programme and a similar structure has been used for alcohol cessation, physical exercise, and nutrition interventions. All participants in the intervention group will receive immunonutrition in the days before surgery.

Treatment:

Behavioral: Prehabilitation (the STRONG programme)

Treatment as usual

No Intervention group

Description:

Treatment as usual in the preoperative period in the included hospital departments, e.g. brief counselling/advice regarding smoking cessation and weight loss, and handing out the national folders on smoking and surgery. Participants are free to access support to lifestyle changes in the community.