A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite (Sepramesh)
|ClinicalTrials.gov Identifier: NCT01305473|
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : July 18, 2012
Last Update Posted : August 1, 2012
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305473
|United States, Ohio|
|Cornerstone Medical Center|
|Centerville, Ohio, United States, 45459|
|Principal Investigator:||Andrew L Archer, MD||Providence Medical Group and Cornerstone Medical Center|