HerniaPreOptNCT07316426
Preoptimisation in Ventral Hernia Surgery
A study testing preoptimisation programme in people with Hernia and Hernia, Ventral, run by Umeå University at 5 sites in Sweden.
Trial summary
The study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Hernia, Ventral, Hernia Incisional
- What is being tested?
- preoptimisation programme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesSweden
- Study dates
- 22 Sep 2025to 1 Sep 2029
- 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
- Patients with a ventral hernia with a defect width of at least 4 cm.
- Symptom burden related to the hernia sufficient to justify surgical intervention.
- Age ≥ 18 years.
Who cannot join
- Expected survival of less than three years.
- Inability to comprehend oral and written information or to provide informed consent.
- Acute complication of the hernia requiring emergency surgical intervention.
- General condition characterised by severe limitations in physical functional capacity.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Viktor Holmdahl, Phd contact
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Gällivare hospital
Gällivare, Norrbotten County, 98238
Gunnar Nordqvist, MD, 004697019876, gunnar.nordqvist@norrbotten.se
- Recruiting
Sunderby Hospital
Luleå, Norrbotten County, 94542
Gunnar Nordqvist, MD, +46768227094, gunnar.nordqvist@norrbotten.se
Nordqvist, gunnar.nordqvist@norrbotten.se
- Not yet recruiting
Lycksele Hospital
Lycksele, Västerbotten County, 92137
Viktor Holmdahl, MD, Phd, +46730724411, viktor.holmdahl@umu.se
Holmdahl, viktor.holmdahl@umu.se
- Not yet recruiting
Skellefteå Hospital
Skellefteå, Västerbotten County, 93141
Mikael Lindmark, MD, Phd, 0046739649215, mikael.lindmark@umu.se
- Recruiting
Umeå University Hospital
Umeå, Västerbotten County
Viktor Holmdahl, MD, Phd, 0046730724411, viktor.holmdahl@umu.se
About this study
Official title: Preoptimisation in Ventral Hernia Surgery- a Randomised Trial
The study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and optimise the treatment of comorbidities, or to surgery without structured preoptimisation. The primary endpoint is complications at three months postoperatively. During surgery, biopsies of skin, muscle, and fascia will be collected, along with pre- and postoperative blood samples, to analyse the molecular effects of preoptimisation, particularly in relation to collagen metabolism.
- Conditions
- Hernia, Hernia, Ventral, Hernia Incisional, Hernia, Umbilical
- Being tested
- preoptimisation programme
- Keywords
- preoptimisation, prehabilitation
- Medical subject headings
- Hernia, Hernia, Ventral, Incisional Hernia, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoptimisation programmeProcedure or surgery
The intervention group follows a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use. Designed to suit both rural and urban populations in northern Sweden, the programme lasts for a minimum of three months before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption. Receives: Procedure: preoptimisation programme |
| control | No intervention | The control group will receive basic guidance on physical activity and weight management during the preoperative consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications at three months postoperatively
Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.
Measured: 3 months postoperatively
Secondary outcomes (13)
Complications at twelve months postoperatively
Incidence of surgical and medical complications at 12 months postoperatively.
Measured: 12 months postoperatively
Patient-reported pain
Patient-reported pain measured with Ventral Hernia Pain Questionnaire, VHPQ. Max score is 40 and minimum score is 0, a lower score indicates less abdominal wall pain.
Measured: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Quality of life with EQ-5D
Quality of life assessed using the EuroQol 5-Dimensions questionnaire (EQ-5D index score). Max score is 1.0, which equals to perfect health and a lower score indicates lower quality of life with 0 is equivalent to death. Negative scores indicated health states considered worse than dead (e.g. severe disability).
Measured: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Aesthetic outcome
Patient reported aestethic outcome measured with a Numerical Ratin Scale, NRS scale, range 1-10 where a higher score indicates better patient reported aesthetic outcome.
Measured: Measured at clinical follow-upat 3 and 12 months postoperatively.
Recurrence rate
Recurrence of ventral hernia.
Measured: Measured at clinical follow-up at 3 and 12 months postoperatively.
Change in physical activity
changes in physical activity measured with accelerometer for one week.
Measured: meassured close to inclusion and within a few weeks preoperatively.
Weight
Weight measured i kg.
Measured: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Collagen metabolism
Difference between study groups in the expression levels of a panel of markers of collagen degradation and synthesis (including CHP, Collagen 1 and 4, MMP) in tissue samples taken from fascia, muscle and skin.
Measured: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
Hba1c
Hba1c in bloodsamples
Measured: at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.
Hernia aperature width
Hernia aperature width
Measured: measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion
B-PETH
B-PETH
Measured: at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.
Rutine labarotory tests
Number of participants with abnormal routine laboratory tests results
Measured: At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively
Hyaluronan metabolism
Difference between study groups in the expression patterns and histological distribution of hyaluronan and hyaluronan metabolism-related factors (including CD44, TRAMM, and hyaluronidases) in tissue samples taken from fascia, muscle and skin.
Measured: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start22 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- This study is a prospective, single-blinded, multicentre, randomised, controlled superiority trial employing a parallel-group design with an allocation ratio of 1:1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Norrbotten, Region Västerbotten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316426
- Sponsor's protocol ID
- PreOpt
- Acronym
- PreOpt
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoptimisation in Ventral Hernia Surgery- a Randomised Trial
- ClinicalTrials.gov ID
- NCT07316426
- Acronym / sponsor ID
- PreOpt / PreOpt
- Conditions
- Hernia, Hernia, Ventral, Hernia Incisional, Hernia, Umbilical
- Keywords
- preoptimisation, prehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Norrbotten, Region Västerbotten
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 5 Jan 2026 (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 study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and optimise the treatment of comorbidities, or to surgery without structured preoptimisation. The primary endpoint is complications at three months postoperatively. During surgery, biopsies of skin, muscle, and fascia will be collected, along with pre- and postoperative blood samples, to analyse the molecular effects of preoptimisation, particularly in relation to collagen metabolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, single-blinded, multicentre, randomised, controlled superiority trial employing a parallel-group design with an allocation ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: preoptimisation programmeThe intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption. |
| control | No intervention | –The control group will receive basic guidance on physical activity and weight management during the preoperative consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a ventral hernia with a defect width of at least 4 cm.
- Symptom burden related to the hernia sufficient to justify surgical intervention.
- Age ≥ 18 years.
Key exclusion criteria (4 listed)
- Expected survival of less than three years.
- Inability to comprehend oral and written information or to provide informed consent.
- Acute complication of the hernia requiring emergency surgical intervention.
- General condition characterised by severe limitations in physical functional capacity.
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 |
|---|---|---|
| preoptimisation programmeThe intervention group follows a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use. Designed to suit both rural and urban populations in northern Sweden, the programme lasts for a minimum of three months before surgery. | Procedure or surgery | Intervention |
Primary outcome
Complications at three months postoperatively
Time frame: 3 months postoperatively
Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.
13 secondary outcomes
Complications at twelve months postoperatively
Time frame: 12 months postoperatively
Patient-reported pain
Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Quality of life with EQ-5D
Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Aesthetic outcome
Time frame: Measured at clinical follow-upat 3 and 12 months postoperatively.
Recurrence rate
Time frame: Measured at clinical follow-up at 3 and 12 months postoperatively.
Change in physical activity
Time frame: meassured close to inclusion and within a few weeks preoperatively.
Weight
Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Collagen metabolism
Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
Hba1c
Time frame: at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.
Hernia aperature width
Time frame: measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion
B-PETH
Time frame: at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.
Rutine labarotory tests
Time frame: At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively
Hyaluronan metabolism
Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Viktor Holmdahl, Phd contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoptimisation programme in people with Hernia and Hernia, Ventral, run by Umeå University at 5 sites in Sweden.
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 3 inclusion and 4 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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 Gunnar Nordqvist, M.D. (+46768227094, gunnar.nordqvist@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications at three months postoperatively (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.