A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
NCT ID: NCT02341430
Last Updated: 2019-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2016-01-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
TRIPLE
Interventions
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Symbotex™ Composite Mesh
Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh
Eligibility Criteria
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Inclusion Criteria
* Grade I or II ventral hernia according to VHWG classification system
* Pre-operative informed consent is obtainable
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Anne Arundel Health System Research Institute
OTHER
Responsible Party
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Principal Investigators
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Adrian Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Anne Arundel Medical Center
Locations
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Anne Arundel Medical Center
Annapolis, Maryland, United States
Countries
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References
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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.
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. doi: 10.1097/01.sla.0000086662.49499.ab.
SymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013)
Malangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135
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.
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.
Other Identifiers
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689069
Identifier Type: -
Identifier Source: org_study_id
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