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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01305473
First received: February 25, 2011
Last updated: July 31, 2012
Last verified: July 2012
  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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01305473     History of Changes
Other Study ID Numbers: DVL-HE007
Study First Received: February 25, 2011
Results First Received: June 12, 2012
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014