An interventional study of Prehabilitation (the STRONG programme) in Ventral Hernia, Surgery and Risk Reduction, sponsored by Bispebjerg Hospital. Recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Prevention
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.
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 400 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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
Postoperative complications within 30 days
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Time frame: 30 days
Postoperative complications within 3 and 6 months
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Time frame: 3 months, 6 months
Comprehensive Complication Index (CCI)
Calculated from the Clavien-Dindo classification of the postoperative complications
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days, 6 months, 2 years
Cost-effectiveness
Calculated as a probability in percent (%)
Time frame: 2 years
Patient expectations
Measured as a number on a VAS scale from 0-10
Time frame: Baseline
Patient reflections 1
Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle
Time frame: Baseline
Patient reflections 2
Qualitative analysis of patient reflections obtained from semi-structured interviews
Time frame: Baseline
Postoperative length of stay
Descriptively reported as total time in hospital within 30 postoperative days with 95% CI
Time frame: From surgery until 30 days postoperative
Readmission
Descriptively reported as number and proportion (in %) of participants with readmission with 95% CI
Time frame: 90 days
Time back to work/usual activities
Descriptively reported, patient reported
Time frame: 30 days, 3 months, 6 months
Hernia recurrence
Descriptively reported as number and proportion of participants with hernia recurrence
Time frame: 90 days
Reoperation for hernia recurrence
Descriptively reported as number and proportion (in %) of participants reoperated for hernia recurrence with 95% CI
Time frame: 90 days
Visits to primary care
Descriptively reported as number and proportion (in %) of participants with any visits to primary care with 95% CI
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2026, 23 months after the start.
Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 23 months is below that.
Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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