RCT Ventralex vs Onlay Mesh in Incisional Hernias

Incisional Hernia of Midline of Abdomen Clinical Trial

— VPatchIncRCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04358159
• Other study ID #: VPatchIncRCT
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 30, 2026

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

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernia of Midline of Abdomen

Intervention

Device:
• Ventralex
Repair of the hernia by a Ventralex patch in sublay position
• Progrip
Repair of the hernia by a Progrip mesh in onlay position

Locations

Country	Name	City	State
Sweden	Karlskoga Hospital	Karlskoga
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	Recurrence rate	Rate of hernia recurrences diagnosed at clinical and/or radiologic examination	One year
Secondary	Rate ofntra- and postoperative complications	Rate of complications occurring during or after the repair	30 days
Secondary	Rate of seroma	Postoperative seroma	one year
Secondary	Persisting postoperative pain	Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire	One year
Secondary	Sick leave	Mean number of postoperative days sick leave	30 days