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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary and Secondary Ventral Hernia
• Intervention / Treatment: Procedure: Placing the resorbable mesh; Procedure: Non-resorbable synthetic mesh.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Leuven, Belgium, 3000
    • University Hospital Leuven
• Denmark
  • Copenhagen, Denmark, DK-2400
    • University of Copenhagen
• Poland
  • Wejherowo, Poland, 84-200
    • ul Jagalskiego
• Spain
  • Madrid, Spain
    • Hospital de 12 Octobre
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary and secondary ventral hernia

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

Exclusion Criteria:

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: Resorbable mesh; Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.	Procedure: Placing the resorbable mesh; Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
Active Comparator: Non-resorbable mesh; Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.	Procedure: Non-resorbable synthetic mesh.; Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate at 3 years post-surgery.	Clinical evaluation and ultrasound evaluation after 3 years post-surgery.	3 years post-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Novus Scientific
• Investigators: Principal Investigator: Frederik Berrevoet, MD, PhD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimated): June 19, 2012

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ventral hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Pathological Conditions, Anatomical; Hernia, Abdominal; Neoplastic Processes; Hernia; Neoplasm Metastasis; Hernia, Ventral
• Other Study ID Numbers: 2012/223