Ventralex vs Stratafix for Primary Ventral Hernias (VPatchPriRCT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Ventralex; Other: Stratafix

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel Sandblom, MD, PhD; Phone Number: +4686162362; Email: gabriel.sandblom@ki.se
• Study Contact Backup: Name: Asmatullah Katawazai, MD; Phone Number: +4658666000; Email: asmatullah.katawazai@regionorebrolan.se

Study Locations

• Sweden
  • Karlskoga, Sweden
    • Recruiting
    • Karlskoga Hospital
    • Contact: Asmatullah Katawazai, MD; Phone Number: +4658666000; Email: asmatullah.katawazai@regionorebrolan.se
    • Contact: Gabriel Sandblom, MD, PhD; Email: gabriel.sandblom@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Defect 1-4 cm
• Primary ventral hernia in the midline
• BMI<35

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventralex; Repair with Ventralex hernia patch in sublay position	Device: Ventralex; Repair of hernia using Ventralex patch in sublay position
Active Comparator: Stratafix; Repair with Stratafix suture	Other: Stratafix; Repair of hernia without mesh. Defect closed with Stratafix suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	Recurrence diagnosed at clinical and/or radiologic examination	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Gabriel Sandblom, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: VPatchPriRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No