A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

NCT01305473 | Completed Results

• 1 other identifier: DVL-HE007
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

• Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.

  A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.

  12 months or greater (average follow-up time of 3 years; range 13-65 months)

Secondary Outcomes (3)

• Complications in Subjects With Hernias Repaired With Sepramesh.

  12 months or greater (average follow-up time of 3 years; range 13-65 months)

• Procedural Time for Sepramesh Placement.

  Day 0

• Recovery Time Associated With Hernias Repaired With Sepramesh.

  12 months or greater (average follow-up time of 3 years; range 13-65 months)

Study Arms (1)

Sepramesh Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have been treated with Sepramesh at least 12 months before starting in this study.

You may qualify if:

• Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
• Have signed an Informed Consent Form (ICF).

You may not qualify if:

• Underwent implantation of Sepramesh for any reason other than ventral hernia repair.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Cornerstone Medical Center

Centerville, Ohio, 45459, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single center study design; incomplete documentation did not permit evaluation of recovery time as pre-specified secondary endpoint.

Results Point of Contact

• Title: Dawn Heimer/Director, Clinical Affairs
• Organization: C.R. Bard: Davol, Inc.

dawn.heimer@crbard.com

401-825-8681

Study Officials

• Andrew L Archer, MD

  Providence Medical Group and Cornerstone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 1, 2012
• Results First Posted: July 18, 2012

Record last verified: 2012-07

Locations

US (1)