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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COMPLETED
NA
200 participants
INTERVENTIONAL
2021-01-01
2024-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ventralex
Repair with Ventralex hernia patch in sublay position
Ventralex
Repair of hernia using Ventralex patch in sublay position
Stratafix
Repair with Stratafix suture
Stratafix
Repair of hernia without mesh. Defect closed with Stratafix suture.
Interventions
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Ventralex
Repair of hernia using Ventralex patch in sublay position
Stratafix
Repair of hernia without mesh. Defect closed with Stratafix suture.
Eligibility Criteria
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Inclusion Criteria
* Primary ventral hernia in the midline
* BMI\<35
Exclusion Criteria
* BMI\>35
* Recurrent 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, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karlskoga Hospital
Karlskoga, , Sweden
Countries
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Other Identifiers
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VPatchPriRCT
Identifier Type: -
Identifier Source: org_study_id
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