Grade I Ventral Hernia Clinical Trial
Official title:
A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
| Verified date | February 2019 |
| Source | Anne Arundel Health System Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | September 11, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Anne Arundel Medical Center | Annapolis | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Anne Arundel Health System Research Institute | Medtronic - MITG |
United States,
Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. — View Citation
Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1. — View Citation
Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18. — View Citation
Malangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135
SymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013)
Ventral Hernia Working Group, Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010 Sep;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. Epub 2010 Mar 20. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hernia Recurrence | One year | ||
| Primary | Quality of Life | One year | ||
| Primary | Hernia associated pain and movement limitations pre-surgery compared to post-surgery | One year | ||
| Primary | Reoperation Rate | One year | ||
| Primary | Percutaneous Intervention Rate | One year | ||
| Primary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability" | One year |