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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sepramesh Group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew L Archer, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Medical Group and Cornerstone Medical Center

Locations

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Cornerstone Medical Center

Centerville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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DVL-HE007

Identifier Type: -

Identifier Source: org_study_id