RCT Ventralex vs Onlay Mesh in Incisional Hernias

Not Applicable

Recruiting

• Conditions: Incisional Hernia of Midline of Abdomen
• Interventions: Device: Progrip; Device: Ventralex

• Registration Number: NCT04358159
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2021-01-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

• Defect size>4 cm
• Ongoing pregnancy
• BMI>35
• Primary hernia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progrip	Progrip	Repair with Progrip in Onlay position
Ventralex	Ventralex	Repair with Ventralex patch in sublay position

Primary Outcome Measures

Name	Time	Method
Recurrence rate	One year	Rate of hernia recurrences diagnosed at clinical and/or radiologic examination

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karlskoga Hospital; 🇸🇪 Karlskoga, Sweden