A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh

Anne Arundel Health System Research Institute

Status and phase

Completed

Phase 4

Conditions

Grade I Ventral Hernia

Grade II Ventral Hernia

Treatments

Device: Symbotex™ Composite Mesh

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02341430

689069

Details and patient eligibility

About

This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.

Full description

This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 or older
Grade I or II ventral hernia according to VHWG classification system
Pre-operative informed consent is obtainable

Exclusion criteria

Not candidate for laparoscopic approach for repair of their hernia
Determination in the operating room that biologic mesh is needed over permanent mesh
Fascial defect less than 3 cm in greatest dimension
Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed
Grade III or IV ventral hernia according to VHWG system
ASA score IV or above
Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation.
Pregnancy
Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.