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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2028-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ventral Hernia Surgery Risk Reduction Lifestyle Postoperative Complications Prehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised parallel design using block randomisation. Stratification for centre and number of SNAP factors (one, two, or ≥ 3).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Statistical analyses will be conducted blinded.

Study Groups

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Prehabilitation

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.

Group Type EXPERIMENTAL

Prehabilitation (the STRONG programme)

Intervention Type BEHAVIORAL

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.

Treatment as usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Smoking cessation Alcohol cessation Physical activity Nutritional support for malnutrition and/or obesity

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No