Ventralex vs Stratafix for Primary Ventral Hernias

Ventral Hernia Clinical Trial

— VPatchPriRCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04356976
• Other study ID #: VPatchPriRCT
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: Gabriel Sandblom, MD, PhD
• Phone: +4686162362
• Email: gabriel.sandblom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Defect 1-4 cm

• Primary ventral hernia in the midline

• BMI<35

Exclusion Criteria:

• Defect >4cm

• BMI>35

• Recurrent hernia

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Ventralex
Repair of hernia using Ventralex patch in sublay position

Other:
• Stratafix
Repair of hernia without mesh. Defect closed with Stratafix suture.

Locations

Country	Name	City	State
Sweden	Karlskoga Hospital	Karlskoga

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	Recurrence diagnosed at clinical and/or radiologic examination	One year
Secondary	Rate of intra-and postoperative complications	Complications occurring intraoperatively or in the postoperative period	30 days
Secondary	Rate of seroma development	Seroma confirmed at follow-up examination	one year
Secondary	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	One year
Secondary	Mean number of days postoperative sick leave	Postoperative sick leave	30 days