Ventralex vs Stratafix for Primary Ventral Hernias

Overview

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

Full Title of Study: “Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2023

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.

Interventions

  • Device: Ventralex
    • Repair of hernia using Ventralex patch in sublay position
  • Other: Stratafix
    • Repair of hernia without mesh. Defect closed with Stratafix suture.

Arms, Groups and Cohorts

  • Experimental: Ventralex
    • Repair with Ventralex hernia patch in sublay position
  • Active Comparator: Stratafix
    • Repair with Stratafix suture

Clinical Trial Outcome Measures

Primary Measures

  • Hernia recurrence
    • Time Frame: One year
    • Recurrence diagnosed at clinical and/or radiologic examination

Secondary Measures

  • Rate of intra-and postoperative complications
    • Time Frame: 30 days
    • Complications occurring intraoperatively or in the postoperative period
  • Rate of seroma development
    • Time Frame: one year
    • Seroma confirmed at follow-up examination
  • Persisting pain
    • Time Frame: One year
    • 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
  • Mean number of days postoperative sick leave
    • Time Frame: 30 days
    • Postoperative sick leave

Participating in This Clinical Trial

Inclusion Criteria

  • Defect 1-4 cm – Primary ventral hernia in the midline – BMI<35 Exclusion Criteria:

  • Defect >4cm – BMI>35 – Recurrent hernia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gabriel Sandblom, Associate Professor – Karolinska Institutet
  • Overall Official(s)
    • Gabriel Sandblom, MD, PhD, Principal Investigator, Karolinska Institutet
  • Overall Contact(s)
    • Gabriel Sandblom, MD, PhD, +4686162362, gabriel.sandblom@ki.se

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