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

Phase 4

Completed

• Conditions: Grade I Ventral Hernia; Grade II Ventral Hernia

• Registration Number: NCT02341430
• Lead Sponsor: Anne Arundel Health System Research Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Study Start: 2016-01
• Primary Completion: 2017-09-11
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reoperation Rate	One year
Hernia Recurrence	One year
Quality of Life	One year
Hernia associated pain and movement limitations pre-surgery compared to post-surgery	One year
Percutaneous Intervention Rate	One year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"	One year

Trial Locations

Locations (1)

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States