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

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

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.

Study Overview

• Status: Completed
• Conditions: Hernia

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Cornerstone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Sepramesh Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications in Subjects With Hernias Repaired With Sepramesh.	Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).	12 months or greater (average follow-up time of 3 years; range 13-65 months)
Procedural Time for Sepramesh Placement.	Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).	Day 0
Recovery Time Associated With Hernias Repaired With Sepramesh.	Recovery time will be defined as the time it took for the subject to return to work.	12 months or greater (average follow-up time of 3 years; range 13-65 months)

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Andrew L Archer, MD, Providence Medical Group and Cornerstone Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: DVL-HE007