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

Primary Purpose

Primary and Secondary Ventral Hernia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Placing the resorbable mesh
Non-resorbable synthetic mesh.
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary and Secondary Ventral Hernia focused on measuring ventral hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary and secondary ventral hernia

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

Exclusion Criteria:

Sites / Locations

  • Ghent University Hospital
  • University Hospital Leuven
  • University of Copenhagen
  • ul Jagalskiego
  • Hospital de 12 Octobre
  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resorbable mesh

Non-resorbable mesh

Arm Description

Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.

Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2012
Last Updated
August 31, 2023
Sponsor
University Hospital, Ghent
Collaborators
Novus Scientific
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1. Study Identification

Unique Protocol Identification Number
NCT01622725
Brief Title
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Acronym
TIGR
Official Title
Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2013 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Novus Scientific

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary and Secondary Ventral Hernia
Keywords
ventral hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resorbable mesh
Arm Type
Experimental
Arm Description
Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.
Arm Title
Non-resorbable mesh
Arm Type
Active Comparator
Arm Description
Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.
Intervention Type
Procedure
Intervention Name(s)
Placing the resorbable mesh
Intervention Description
Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
Intervention Type
Procedure
Intervention Name(s)
Non-resorbable synthetic mesh.
Intervention Description
Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.
Primary Outcome Measure Information:
Title
Recurrence rate at 3 years post-surgery.
Description
Clinical evaluation and ultrasound evaluation after 3 years post-surgery.
Time Frame
3 years post-surgery
Secondary Outcome Measure Information:
Title
Wound Morbidity 4 weeks post-surgery.
Time Frame
4 weeks post-surgery
Title
Pain and discomfort after 1 year post-surgery.
Time Frame
After 1 year post-surgery
Title
Pain and discomfort after 3 years post-surgery.
Time Frame
After 3 years post-surgery
Title
Recurrence rate by clinical examination 1 year post-surgery.
Description
Clinical Examination to determine the recurrence rate.
Time Frame
After 1 year post-surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary and secondary ventral hernia less than 20 cm in length less than 6 cm in width Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
Facility Name
ul Jagalskiego
City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
Facility Name
Hospital de 12 Octobre
City
Madrid
Country
Spain
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

Learn more about this trial

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

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