Ventral HerniaVPatchPriRCTNCT04356976
Ventralex Vs Stratafix for Primary Ventral Hernias
A study testing Ventralex and Stratafix in people with Ventral Hernia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Ventralex and Stratafix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Defect 1-4 cm
- Primary ventral hernia in the midline
- BMI<35
Who cannot join
- Defect >4cm
- BMI>35
- Recurrent hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias
Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.
Read the detailed description
Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery.
Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery.
The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.
- Conditions
- Ventral Hernia
- Being tested
- Ventralex, Stratafix
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentralexDevice
Repair of hernia using Ventralex patch in sublay position
StratafixOther
Repair of hernia without mesh. Defect closed with Stratafix suture.
| Study group | Role | What they receive |
|---|---|---|
| Ventralex | Experimental | Repair with Ventralex hernia patch in sublay position Receives: Device: Ventralex |
| Stratafix | Active comparator | Repair with Stratafix suture Receives: Other: Stratafix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Recurrence diagnosed at clinical and/or radiologic examination
Measured: One year
Secondary outcomes (4)
Rate of intra-and postoperative complications
Complications occurring intraoperatively or in the postoperative period
Measured: 30 days
Rate of seroma development
Seroma confirmed at follow-up examination
Measured: one year
Persisting pain
Postoperative pain rated with the Ventral Hernia Pain Questionnaire. Pain rated on a scale from 1 to 7, with higher scores indicating more severe pain
Measured: One year
Mean number of days postoperative sick leave
Postoperative 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 posted22 Apr 2020
- Study start1 Jan 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies 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 comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
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, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356976
- Sponsor's protocol ID
- VPatchPriRCT
- Acronym
- VPatchPriRCT
- Status last verified
- Jan 2025
- First submitted
- 19 Apr 2020
- Last updated
- 3 Jan 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias
- ClinicalTrials.gov ID
- NCT04356976
- Acronym / sponsor ID
- VPatchPriRCT / VPatchPriRCT
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 22 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.
Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.
Detailed description
Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery.
Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery.
The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.
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 comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias
| Arm | Type | Receives |
|---|---|---|
| Ventralex | Experimental | Device: VentralexRepair with Ventralex hernia patch in sublay position |
| Stratafix | Active comparator | Other: StratafixRepair with Stratafix suture |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Defect 1-4 cm
- Primary ventral hernia in the midline
- BMI<35
Key exclusion criteria (3 listed)
- Defect >4cm
- BMI>35
- Recurrent 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 hernia using Ventralex patch in sublay position | Device | Ventralex |
| StratafixRepair of hernia without mesh. Defect closed with Stratafix suture. | Other | Stratafix |
Primary outcome
Hernia recurrence
Time frame: One year
Recurrence diagnosed at clinical and/or radiologic examination
4 secondary outcomes
Rate of intra-and postoperative complications
Time frame: 30 days
Rate of seroma development
Time frame: one year
Persisting pain
Time frame: One year
Mean number of days postoperative sick leave
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Ventral Hernia
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
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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. This study is not recruiting at the moment.
Gabriel Sandblom, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventralex and Stratafix in people with Ventral Hernia, run by Karolinska Institutet at 1 site 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 3 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: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence (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 3 Jan 2025.