Ventralex Vs Stratafix for Primary Ventral Hernias (VPatchPriRCT)
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About
Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
- Defect 1-4 cm
- Primary ventral hernia in the midline
- BMI<35
Exclusion criteria
- Defect >4cm
- BMI>35
- Recurrent hernia
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Asmatullah Katawazai, MD; Gabriel Sandblom, MD, PhD
Data sourced from clinicaltrials.gov
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