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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305473
First Posted: February 28, 2011
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
  Purpose

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.


Condition
Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. [ Time Frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months) ]
    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.


Secondary Outcome Measures:
  • Complications in Subjects With Hernias Repaired With Sepramesh. [ Time Frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months) ]
    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).

  • Procedural Time for Sepramesh Placement. [ Time Frame: Day 0 ]
    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).

  • Recovery Time Associated With Hernias Repaired With Sepramesh. [ Time Frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months) ]
    Recovery time will be defined as the time it took for the subject to return to work.


Enrollment: 90
Study Start Date: August 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sepramesh Group

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have been treated with Sepramesh at least 12 months before starting in this study.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305473


Locations
United States, Ohio
Cornerstone Medical Center
Centerville, Ohio, United States, 45459
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Andrew L Archer, MD Providence Medical Group and Cornerstone Medical Center
  More Information

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01305473     History of Changes
Other Study ID Numbers: DVL-HE007
First Submitted: February 25, 2011
First Posted: February 28, 2011
Results First Submitted: June 12, 2012
Results First Posted: July 18, 2012
Last Update Posted: August 1, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal