RCT Ventralex vs Onlay Mesh in Incisional Hernias (VPatchIncRCT)

Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias

A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias

Study Overview

• Status: Recruiting
• Conditions: Incisional Hernia of Midline of Abdomen
• Intervention / Treatment: Device: Ventralex; Device: Progrip

Detailed Description

Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.

Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.

• 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: +46586660 00; Email: asmatullah.katawazai@regionorebrolan.se

Study Locations

• Sweden
  • Karlskoga, Sweden
    • Recruiting
    • Karlskoga Hospital
    • Contact: Gabriel Sandblom, MD, PhD; Email: gabriel.sandblom@ki.se
    • Contact: Asmatullah Katawazai, MD; Email: asmatullah.katawazai@regionorebrolan.se
  • Karlskoga, Sweden
    • Not yet recruiting
    • Karlskoga Hospital
    • Contact: Asmatullah Katawazai, MD

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:

• Hernia defect 1-4 cm
• Incisional hernia or recurrent hernia after previous primary hernia repair
• BMI <35
• Age 18-100 years

Exclusion Criteria:

• Defect size>4 cm
• Ongoing pregnancy
• BMI>35
• Primary 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 patch in sublay position	Device: Ventralex; Repair of the hernia by a Ventralex patch in sublay position
Active Comparator: Progrip; Repair with Progrip in Onlay position	Device: Progrip; Repair of the hernia by a Progrip mesh in onlay position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Rate of hernia recurrences diagnosed at clinical and/or radiologic examination	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate ofntra- and postoperative complications	Rate of complications occurring during or after the repair	30 days
Rate of seroma	Postoperative seroma	one year
Persisting postoperative pain	Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire	One year
Sick leave	Mean number of postoperative days sick leave	30 days

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Gabriel Sandblom, MD, 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 24, 2020

Study Record Updates

• Last Update Posted (Estimate): 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: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: VPatchIncRCT

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