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Completed

NCT Number: NCT01305473

A 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.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cornerstone Medical Center

Centerville, Ohio, 45459, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Acronym: Sepramesh

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2011
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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