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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Surgery; Ventral Hernia; Risk Reduction; Lifestyle; Prehabilitation
• Intervention / Treatment: Behavioral: Prehabilitation (the STRONG programme)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanne Tønnesen, Professor MD; Phone Number: +4538163840; Email: hanne.tonnesen@regionh.dk
• Study Contact Backup: Name: Sofie AS Jensen, MD; Email: sofie.anne-marie.skovbo.jensen.01@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Copenhagen University Hospital at Herlev
    • Contact: Jacob Rosenberg, Professor, surgeon; Phone Number: +4538689504; Email: jacob.rosenberg@regionh.dk
  • Holbæk, Denmark, 4300
    • Not yet recruiting
    • Holbaek Sygehus
    • Contact: Birgitte Brandstrup, Associate Professor, surgeon; Phone Number: +4523476009; Email: bbrn@regionsjaelland.dk
  • Køge, Denmark, 4600
    • Not yet recruiting
    • Zealand University Hospital
    • Contact: Frederik Helgstrand, Associate Professor, surgeon; Phone Number: +4523348764; Email: freh@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Physical activity; Smoking cessation; Alcohol cessation; Nutritional support for malnutrition and/or obesity
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications within 30 days	Number and proportion of participants with at least one postoperative complication defined by requiring treatment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications within 3 and 6 months	Number and proportion of participants with at least one postoperative complication defined by requiring treatment	3 months, 6 months
Comprehensive Complication Index (CCI)	Calculated from the Clavien-Dindo classification of the postoperative complications	30 days, 3 months, 6 months
Successful quitting of risky lifestyles	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	End of intervention/at surgery, 30 days, 3 months, 6 months
Any improvement of risky lifestyles	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	End of intervention/at surgery, 30 days, 3 months, 6 months
Health-Related Quality of Life (HRQoL)	Number and proportion of patients with improvement of HRQoL compared with baseline. HRQoL is measured by the EQ-5D instrument	End of intervention/at surgery, 30 days, 3 months, 6 months
Costs	Measured as individual direct and indirect healthcare costs per patient based on data from national registries	30 days, 6 months, 2 years
Cost-effectiveness	Calculated as a probability in percent (%)	2 years
Patient expectations	Measured as a number on a VAS scale from 0-10	Baseline
Patient reflections 1	Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle	Baseline
Patient reflections 2	Qualitative analysis of patient reflections obtained from semi-structured interviews	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of stay	Descriptively reported as total time in hospital within 30 postoperative days with 95% CI	From surgery until 30 days postoperative
Readmission	Descriptively reported as number and proportion (in %) of participants with readmission with 95% CI	90 days
Time back to work/usual activities	Descriptively reported, patient reported	30 days, 3 months, 6 months
Hernia recurrence	Descriptively reported as number and proportion of participants with hernia recurrence	90 days
Reoperation for hernia recurrence	Descriptively reported as number and proportion (in %) of participants reoperated for hernia recurrence with 95% CI	90 days
Visits to primary care	Descriptively reported as number and proportion (in %) of participants with any visits to primary care with 95% CI	30 days
Successful quitting of risky lifestyles individually	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	End of intervention/at surgery, 30 days, 3 months, 6 months
Change in ASA score	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	End of intervention/at surgery, 30 days, 3 months, 6 months
Change of frailty	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.	End of intervention/at surgery, 30 days, 3 months, 6 months
Morbidity	Descriptively reported as grouped diagnoses via the Danish version of ICD-10 based on data from the Danish National Patient Registry.	2 years

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Zealand University Hospital; Copenhagen University Hospital at Herlev; Holbaek Sygehus
• Investigators: Principal Investigator: Hanne Tønnesen, Professor MD, WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Surgery; Smoking; Alcohol drinking; Malnutrition; Prehabilitation; Postoperative Complications; Risk Reduction; Physical Inactivity; Ventral Hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Postoperative Complications; Hernia, Ventral
• Other Study ID Numbers: H-23028872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No