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NCT Number: NCT06611462

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

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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Key information

Conditions

Ventral Hernia Alcohol Drinking Behavior Body Weight Drinking Behavior Hernia Hernia, Abdominal Hernia, Ventral Lifestyle Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Prehabilitation Risk Reduction Risk Reduction Behavior Sedentary Behavior Signs and Symptoms Smoking Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital at Herlev, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation (the STRONG programme)

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.

Other names: Smoking cessation, Alcohol cessation, Physical activity, Nutritional support for malnutrition and/or obesity

Primary outcomes

  1. Postoperative complications within 30 days

    Time frame: 30 days

    Number and proportion of participants with at least one postoperative complication defined by requiring treatment

Secondary outcomes

  1. Postoperative complications within 3 and 6 months

    Time frame: 3 months, 6 months

    Number and proportion of participants with at least one postoperative complication defined by requiring treatment

  2. Comprehensive Complication Index (CCI)

    Time frame: 30 days, 3 months, 6 months

    Calculated from the Clavien-Dindo classification of the postoperative complications

  3. Successful quitting of risky lifestyles

    Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months

    Number and proportion of participants without all of their preoperative risky lifestyles (identified at baseline). Successful quitting of risky lifestyles are defined as:

    • Smoking: no use of any tobacco products
    • Malnutrition: not at risk of malnutrition defined as NRS <3
    • Obesity: 5-10 % loss of body fat mass compared to baseline
    • Alcohol: Zero alcohol intake at end of intervention/surgery and below risky limits (<14 units per week) at postoperative follow-ups
    • Physical inactivity: being physically active at least 3.5 hours per week

  4. Any improvement of risky lifestyles

    Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months

    Number and proportion of participants with any improvement of any of their risky lifestyles compared with baseline. Any improvements include:

    • Smoking: a reduced number of cigarettes
    • Malnutrition: improvement in level of malnutrition (NRS scale)
    • Obesity: any loss of body fat mass
    • Alcohol: a reduced alcohol intake weekly (reduced number of units weekly)
    • Physical inactivity: Any improvement in minutes of daily physical activity

  5. Health-Related Quality of Life (HRQoL)

    Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months

    Number and proportion of patients with improvement of HRQoL compared with baseline. HRQoL is measured by the EQ-5D instrument

  6. Costs

    Time frame: 30 days, 6 months, 2 years

    Measured as individual direct and indirect healthcare costs per patient based on data from national registries

  7. Cost-effectiveness

    Time frame: 2 years

    Calculated as a probability in percent (%)

  8. Patient expectations

    Time frame: Baseline

    Measured as a number on a VAS scale from 0-10

  9. Patient reflections 1

    Time frame: Baseline

    Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle

  10. Patient reflections 2

    Time frame: Baseline

    Qualitative analysis of patient reflections obtained from semi-structured interviews

Other outcomes

  1. Postoperative length of stay

    Time frame: From surgery until 30 days postoperative

    Descriptively reported as total time in hospital within 30 postoperative days with 95% CI

  2. Readmission

    Time frame: 90 days

    Descriptively reported as number and proportion (in %) of participants with readmission with 95% CI

  3. Time back to work/usual activities

    Time frame: 30 days, 3 months, 6 months

    Descriptively reported, patient reported

  4. Hernia recurrence

    Time frame: 90 days

    Descriptively reported as number and proportion of participants with hernia recurrence

  5. Reoperation for hernia recurrence

    Time frame: 90 days

    Descriptively reported as number and proportion (in %) of participants reoperated for hernia recurrence with 95% CI

  6. Visits to primary care

    Time frame: 30 days

    Descriptively reported as number and proportion (in %) of participants with any visits to primary care with 95% CI

  7. Successful quitting of risky lifestyles individually

    Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months

    Descriptively reported as number and proportion (in%) of participants without their preoperative risky lifestyle (identified at baseline) with 95% CI. Each lifestyle is reported separately. Successful quitting of risky lifestyles are defined as:

    • Smoking: no use of any tobacco products
    • Malnutrition: not at risk of malnutrition defined as NRS <3
    • Obesity: 5-10 % loss of body fat mass compared to baseline
    • Alcohol: Zero alcohol intake at end of intervention/surgery and below risky limits (<14 units per week) at postoperative follow-ups
    • Physical inactivity: being physically active at least 3.5 hours per week

  8. Change in ASA score

    Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months

    Descriptively reported as number and proportion (in %) of participants with change in ASA score level compared with baseline related to a change in risky SNAP factors with 95% CI

  9. Change of frailty

    Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months

    Descriptively reported as number and proportion (in %) of participants with change in frailty score compared with baseline with 95% CI. Measured by Fried's Modified Frailty Score.

  10. Morbidity

    Time frame: 2 years

    Descriptively reported as grouped diagnoses via the Danish version of ICD-10 based on data from the Danish National Patient Registry.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanne Tønnesen, Professor MD

CONTACT

[email protected]

+4538163840

Sofie AS Jensen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Copenhagen University Hospital at Herlev
  • Holbaek Sygehus
  • Zealand University Hospital

Registry information

Official study title

Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)

Acronym: STRONG-Hernia

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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