Incisional Hernia of Midline of AbdomenVPatchIncRCTNCT04358159
RCT Ventralex vs Onlay Mesh in Incisional Hernias
A study testing Ventralex and Progrip in people with Incisional Hernia of Midline of Abdomen, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Incisional Hernia of Midline of Abdomen
- What is being tested?
- Ventralex and Progrip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2021to 30 Sep 2027
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hernia defect 1-4 cm
- Incisional hernia or recurrent hernia after previous primary hernia repair
- BMI <35
- Age 18-100 years
Who cannot join
- Defect size>4 cm
- Ongoing pregnancy
- BMI>35
- Primary hernia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Karlskoga Hospital
Karlskoga
Asmatullah Katawazai, MD
- Recruiting
Karlskoga Hospital
Karlskoga
Asmatullah Katawazai, MD, asmatullah.katawazai@regionorebrolan.se
Gabriel Sandblom, MD, PhD, gabriel.sandblom@ki.se
About this study
Official title: Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias
A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias
Read the detailed description
Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.
Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.
- Conditions
- Incisional Hernia of Midline of Abdomen
- Being tested
- Ventralex, Progrip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentralexDevice
Repair of the hernia by a Ventralex patch in sublay position
ProgripDevice
Repair of the hernia by a Progrip mesh in onlay position
| Study group | Role | What they receive |
|---|---|---|
| Ventralex | Experimental | Repair with Ventralex patch in sublay position Receives: Device: Ventralex |
| Progrip | Active comparator | Repair with Progrip in Onlay position Receives: Device: Progrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Rate of hernia recurrences diagnosed at clinical and/or radiologic examination
Measured: One year
Secondary outcomes (4)
Rate ofntra- and postoperative complications
Rate of complications occurring during or after the repair
Measured: 30 days
Rate of seroma
Postoperative seroma
Measured: one year
Persisting postoperative pain
Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire
Measured: One year
Sick leave
Mean number of postoperative days sick leave
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Midline of AbdomenStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Sandblom, Karolinska Institutet
- Investigators
- Gabriel Sandblom, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358159
- Sponsor's protocol ID
- VPatchIncRCT
- Acronym
- VPatchIncRCT
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias
- ClinicalTrials.gov ID
- NCT04358159
- Acronym / sponsor ID
- VPatchIncRCT / VPatchIncRCT
- Conditions
- Incisional Hernia of Midline of Abdomen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Apr 2020 (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.
A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias
Detailed description
Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.
Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
| Arm | Type | Receives |
|---|---|---|
| Ventralex | Experimental | Device: VentralexRepair with Ventralex patch in sublay position |
| Progrip | Active comparator | Device: ProgripRepair with Progrip in Onlay position |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hernia defect 1-4 cm
- Incisional hernia or recurrent hernia after previous primary hernia repair
- BMI <35
- Age 18-100 years
Key exclusion criteria (4 listed)
- Defect size>4 cm
- Ongoing pregnancy
- BMI>35
- Primary hernia
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 |
|---|---|---|
| VentralexRepair of the hernia by a Ventralex patch in sublay position | Device | Ventralex |
| ProgripRepair of the hernia by a Progrip mesh in onlay position | Device | Progrip |
Primary outcome
Recurrence rate
Time frame: One year
Rate of hernia recurrences diagnosed at clinical and/or radiologic examination
4 secondary outcomes
Rate ofntra- and postoperative complications
Time frame: 30 days
Rate of seroma
Time frame: one year
Persisting postoperative pain
Time frame: One year
Sick leave
Time frame: 30 days
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 13 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Incisional Hernia of Midline of Abdomen
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Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
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Incisional Hernia After Midline Laparotomy, Colorectal Cancer
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Fascial Abdominal Closure Evaluation
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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.
Gabriel Sandblom, MD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventralex and Progrip in people with Incisional Hernia of Midline of Abdomen, run by Karolinska Institutet at 2 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 4 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Gabriel Sandblom, MD, PhD (+4686162362, gabriel.sandblom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: One year). 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 13 Aug 2025.