NCT04356976

Ventralex Vs Stratafix for Primary Ventral Hernias

Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Ventralex	Repair of hernia using Ventralex patch in sublay position
OTHER	Stratafix	Repair of hernia without mesh. Defect closed with Stratafix suture.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2020-04-22
• Last updated: 2025-01-03

Locations

1 site across 1 country: Sweden