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

NCT06611462 | Recruiting

• 1 other identifier: H-23028872
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Ventral Hernia; Surgery; Risk Reduction; Postoperative Complications; Prehabilitation; Smoking; Alcohol drinking; Obesity; Malnutrition; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• Postoperative complications within 30 days

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

  30 days

Secondary Outcomes (10)

• Postoperative complications within 3 and 6 months

  3 months, 6 months

• Comprehensive Complication Index (CCI)

  30 days, 3 months, 6 months

• Successful quitting of risky lifestyles

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

• Any improvement of risky lifestyles

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

• Health-Related Quality of Life (HRQoL)

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

Other Outcomes (10)

• Postoperative length of stay

  From surgery until 30 days postoperative

• Readmission

  90 days

• Time back to work/usual activities

  30 days, 3 months, 6 months

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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.

Behavioral: Prehabilitation (the STRONG programme)

Treatment as usual

NO INTERVENTION

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.

Interventions

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.

Also known as: Smoking cessation, Alcohol cessation, Physical activity, Nutritional support for malnutrition and/or obesity

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Copenhagen University Hospital at Herlev: collaborator
• Zealand University Hospital: collaborator
• Holbaek Sygehus: collaborator

Study Sites (3)

Copenhagen University Hospital at Herlev

Herlev, 2730, Denmark

RECRUITING

Holbaek Sygehus

Holbæk, 4300, Denmark

NOT YET RECRUITING

Zealand University Hospital

Køge, 4600, Denmark

NOT YET RECRUITING

Related Publications (1)

• Jensen SAS, Lauridsen SV, Fonnes S, Rosenberg J, Tonnesen H. Effect of tailored, intensive prehabilitation for risky lifestyles before ventral hernia repair on postoperative outcomes, health, and costs - study protocol for a randomised controlled trial (STRONG-Hernia). PLoS One. 2025 May 28;20(5):e0324002. doi: 10.1371/journal.pone.0324002. eCollection 2025.

  PMID: 40435308 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Risk Reduction Behavior; Postoperative Complications; Smoking; Alcohol Drinking; Obesity; Malnutrition; Sedentary Behavior

Interventions

Preoperative Exercise; Ethanol; Exercise; Nutritional Support

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes; Drinking Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Alcohols; Organic Chemicals; Nutrition Therapy

Study Officials

• Hanne Tønnesen, Professor MD

  WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne Tønnesen, Professor MD

CONTACT

+4538163840; hanne.tonnesen@regionh.dk

Sofie AS Jensen, MD

CONTACT

sofie.anne-marie.skovbo.jensen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analyses will be conducted blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD

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

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: September 25, 2024
• Study Start: March 4, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)