Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-01-01
2027-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ventralex
Repair with Ventralex patch in sublay position
Ventralex
Repair of the hernia by a Ventralex patch in sublay position
Progrip
Repair with Progrip in Onlay position
Progrip
Repair of the hernia by a Progrip mesh in onlay position
Interventions
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Ventralex
Repair of the hernia by a Ventralex patch in sublay position
Progrip
Repair of the hernia by a Progrip mesh in onlay position
Eligibility Criteria
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Inclusion Criteria
* Incisional hernia or recurrent hernia after previous primary hernia repair
* BMI \<35
* Age 18-100 years
Exclusion Criteria
* Ongoing pregnancy
* BMI\>35
* Primary hernia
18 Years
100 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Gabriel Sandblom
Associate Professor
Principal Investigators
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Gabriel Sandblom, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karlskoga Hospital
Karlskoga, , Sweden
Karlskoga Hospital
Karlskoga, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Asmatullah Katawazai, MD
Role: primary
Other Identifiers
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VPatchIncRCT
Identifier Type: -
Identifier Source: org_study_id
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