Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01622725
Acronym
TIGR
Enrollment
95
Registered
2012-06-19
Start date
2013-02-28
Completion date
2023-12-31
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary and Secondary Ventral Hernia

Keywords

ventral hernia

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.

Interventions

PROCEDUREPlacing the resorbable mesh

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

PROCEDURENon-resorbable synthetic mesh.

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

Sponsors

Novus Scientific
CollaboratorINDUSTRY
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate at 3 years post-surgery.3 years post-surgeryClinical evaluation and ultrasound evaluation after 3 years post-surgery.

Secondary

MeasureTime frameDescription
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.After 1 year post-surgery.Clinical Examination to determine the recurrence rate.

Countries

Belgium, Denmark, Poland, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026