Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Not Applicable

Completed

• Conditions: Primary and Secondary Ventral Hernia
• Interventions: Procedure: Non-resorbable synthetic mesh.; Procedure: Placing the resorbable mesh

• Registration Number: NCT01622725
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.

The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.

The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).

Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Study Start: 2013-02
• Primary Completion: 2021-08-01
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Primary and secondary ventral hernia

  • less than 20 cm in length
  • less than 6 cm in width

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-resorbable mesh	Non-resorbable synthetic mesh.	Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.
Resorbable mesh	Placing the resorbable mesh	Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 3 years post-surgery.	3 years post-surgery	Clinical evaluation and ultrasound evaluation after 3 years post-surgery.

Secondary Outcome Measures

Name	Time	Method
Pain and discomfort after 1 year post-surgery.	After 1 year post-surgery
Wound Morbidity 4 weeks post-surgery.	4 weeks post-surgery
Recurrence rate by clinical examination 1 year post-surgery.	After 1 year post-surgery.	Clinical Examination to determine the recurrence rate.
Pain and discomfort after 3 years post-surgery.	After 3 years post-surgery

Trial Locations

Locations (6)

University Hospital Leuven; 🇧🇪 Leuven, Belgium

ul Jagalskiego; 🇵🇱 Wejherowo, Poland

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Hospital de 12 Octobre; 🇪🇸 Madrid, Spain

University of Copenhagen; 🇩🇰 Copenhagen, Denmark