Ventral HerniaSTRONG-HerniaNCT06611462
STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
A study testing Prehabilitation (the STRONG programme) in people with Ventral Hernia and Surgery, run by Bispebjerg Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Surgery, Risk Reduction
- What is being tested?
- Prehabilitation (the STRONG programme)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesDenmark
- Study dates
- 4 Mar 2024to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sofie AS Jensen, MD contact
Denmark3 sites, 3 recruiting
- Recruiting
Copenhagen University Hospital at Herlev
Herlev, 2730
Jacob Rosenberg, Professor, surgeon, +4538689504, jacob.rosenberg@regionh.dk
- Not yet recruiting
Holbaek Sygehus
Holbæk, 4300
Birgitte Brandstrup, Associate Professor, surgeon, +4523476009, bbrn@regionsjaelland.dk
- Not yet recruiting
Zealand University Hospital
Køge, 4600
Frederik Helgstrand, Associate Professor, surgeon, +4523348764, freh@regionsjaelland.dk
About this study
Official 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)
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.
Read the 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.
- Conditions
- Ventral Hernia, Surgery, Risk Reduction, Lifestyle, Postoperative Complications, Prehabilitation
- Being tested
- Prehabilitation (the STRONG programme)
- Keywords
- Ventral Hernia, Surgery, Risk Reduction, Postoperative Complications, Prehabilitation, Smoking, Alcohol drinking, Obesity, Malnutrition, Physical Inactivity
- Medical subject headings
- Hernia, Ventral, Risk Reduction Behavior, Postoperative Complications, Smoking, Alcohol Drinking, Obesity, Malnutrition, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation (the STRONG programme)Behavioural
Also called Smoking cessation, Alcohol cessation, Physical activity, Nutritional support for malnutrition and/or obesity
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications within 30 days
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Measured: 30 days
Secondary outcomes (10)
Postoperative complications within 3 and 6 months
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
Measured: 3 months, 6 months
Comprehensive Complication Index (CCI)
Calculated from the Clavien-Dindo classification of the postoperative complications
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days, 6 months, 2 years
Cost-effectiveness
Calculated as a probability in percent (%)
Measured: 2 years
Patient expectations
Measured as a number on a VAS scale from 0-10
Measured: Baseline
Patient reflections 1
Qualitative analysis of patients reflections on advantages and disadvantages of changing or continuing current lifestyle
Measured: Baseline
Patient reflections 2
Qualitative analysis of patient reflections obtained from semi-structured interviews
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start4 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised parallel design using block randomisation. Stratification for centre and number of SNAP factors (one, two, or ≥ 3).
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Zealand University Hospital, Holbaek Sygehus
- Responsible party
- Principal investigator, Hanne Tonnesen, Bispebjerg Hospital
- Investigators
- Hanne Tønnesen, Professor MD, Principal investigator, WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611462
- Sponsor's protocol ID
- H-23028872
- Acronym
- STRONG-Hernia
- Status last verified
- Sep 2024
- First submitted
- 13 Feb 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40435308
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06611462
- Acronym / sponsor ID
- STRONG-Hernia / H-23028872
- Conditions
- Ventral Hernia, Surgery, Risk Reduction, Lifestyle, Postoperative Complications, Prehabilitation
- Keywords
- Ventral Hernia, Surgery, Risk Reduction, Postoperative Complications, Prehabilitation, Smoking, Alcohol drinking, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Zealand University Hospital, Holbaek Sygehus
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised parallel design using block randomisation. Stratification for centre and number of SNAP factors (one, two, or ≥ 3).
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Prehabilitation (the STRONG programme)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation (the STRONG programme)Also: Smoking cessation, Alcohol cessation, Physical activity, Nutritional support for malnutrition and/or obesityParticipants 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. | Behavioural | Prehabilitation |
Primary outcome
Postoperative complications within 30 days
Time frame: 30 days
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
10 secondary outcomes
Postoperative complications within 3 and 6 months
Time frame: 3 months, 6 months
Comprehensive Complication Index (CCI)
Time frame: 30 days, 3 months, 6 months
Successful quitting of risky lifestyles
Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months
Any improvement of risky lifestyles
Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months
Health-Related Quality of Life (HRQoL)
Time frame: End of intervention/at surgery, 30 days, 3 months, 6 months
Costs
Time frame: 30 days, 6 months, 2 years
Cost-effectiveness
Time frame: 2 years
Patient expectations
Time frame: Baseline
Patient reflections 1
Time frame: Baseline
Patient reflections 2
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 40435308Jensen 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.
- Individual participant dataSharing planned: No
Related trials for Ventral Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofie AS Jensen, MD contact
Hanne Tønnesen, Professor MD principal investigator
WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation (the STRONG programme) in people with Ventral Hernia and Surgery, run by Bispebjerg Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanne Tønnesen, Professor MD (+4538163840, hanne.tonnesen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications within 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.