Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Copenhagen University Hospital at Herlev | OTHER |
| Zealand University Hospital | OTHER |
| Holbaek Sygehus | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanne Tønnesen, Professor MD | Contact | +4538163840 | hanne.tonnesen@regionh.dk | |
| Sofie AS Jensen, MD | Contact | sofie.anne-marie.skovbo.jensen.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Hanne Tønnesen, Professor MD | WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital at Herlev | Recruiting | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40435308 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomised parallel design using block randomisation. Stratification for centre and number of SNAP factors (one, two, or ≥ 3).
Not provided
Not provided
Statistical analyses will be conducted blinded.
Not provided
|
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:
| 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:
| 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 |
| 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:
| 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 |
| Holbaek Sygehus | Not yet recruiting | Holbæk | 4300 | Denmark |
|
| Zealand University Hospital | Not yet recruiting | Køge | 4600 | Denmark |
|
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D040242 | Risk Reduction Behavior |
| D011183 | Postoperative Complications |
| D012907 | Smoking |
| D000428 | Alcohol Drinking |
| D009765 | Obesity |
| D044342 | Malnutrition |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D004327 | Drinking Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D000431 | Ethanol |
| D015444 | Exercise |
| D018529 | Nutritional Support |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D044623 | Nutrition Therapy |
Not provided
Not provided