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Completed

NCT Number: NCT01622725

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary and secondary ventral hernia
  • less than 20 cm in length
  • less than 6 cm in width

Exclusion criteria

Treatment and study plan

Placing the resorbable mesh

Procedure

Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.

Non-resorbable synthetic mesh.

Procedure

Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.

Primary outcomes

  1. Recurrence rate at 3 years post-surgery.

    Time frame: 3 years post-surgery

    Clinical evaluation and ultrasound evaluation after 3 years post-surgery.

Secondary outcomes

  1. Wound Morbidity 4 weeks post-surgery.

    Time frame: 4 weeks post-surgery

  2. Pain and discomfort after 1 year post-surgery.

    Time frame: After 1 year post-surgery

  3. Pain and discomfort after 3 years post-surgery.

    Time frame: After 3 years post-surgery

  4. Recurrence rate by clinical examination 1 year post-surgery.

    Time frame: After 1 year post-surgery.

    Clinical Examination to determine the recurrence rate.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Novus Scientific

Registry information

Official study title

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

Acronym: TIGR

Important dates

Study start
2013
Primary completion
2021
Study completion
2023
First posted
Jun 19, 2012
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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