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

Primary Purpose

Grade I Ventral Hernia, Grade II Ventral Hernia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Symbotex™ Composite Mesh

About this trial

This is an interventional treatment trial for Grade I Ventral Hernia focused on measuring hernia, synthetic mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Anne Arundel Medical Center

Outcomes

Primary Outcome Measures

Hernia Recurrence

Quality of Life

Hernia associated pain and movement limitations pre-surgery compared to post-surgery

Reoperation Rate

Percutaneous Intervention Rate

Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

Secondary Outcome Measures

Full Information

NCT ID

NCT02341430

First Posted

January 8, 2015

Last Updated

February 6, 2019

Sponsor

Anne Arundel Health System Research Institute

Collaborators

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT02341430

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

September 11, 2017 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anne Arundel Health System Research Institute

Collaborators

Medtronic - MITG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Grade I Ventral Hernia, Grade II Ventral Hernia

Keywords

hernia, synthetic mesh

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Symbotex™ Composite Mesh

Intervention Description

Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh

Primary Outcome Measure Information:

Title

Hernia Recurrence

Time Frame

One year

Title

Quality of Life

Time Frame

One year

Title

Hernia associated pain and movement limitations pre-surgery compared to post-surgery

Time Frame

One year

Title

Reoperation Rate

Time Frame

One year

Title

Percutaneous Intervention Rate

Time Frame

One year

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Park, M.D.

Organizational Affiliation

Anne Arundel Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anne Arundel Medical Center

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20304452

Citation

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.

Results Reference

background

PubMed Identifier

14501505

Citation

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.

Results Reference

background

Citation

SymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013)

Results Reference

background

Citation

Malangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135

Results Reference

background

PubMed Identifier

18387468

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.

Results Reference

background

PubMed Identifier

20404280

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.

Results Reference

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

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