A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
- Conditions
- Hernia
- Registration Number
- NCT01305473
- Lead Sponsor
- C. R. Bard
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
- Have signed an Informed Consent Form (ICF).
- Underwent implantation of Sepramesh for any reason other than ventral hernia repair.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. 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
Name Time Method Complications in Subjects With Hernias Repaired With Sepramesh. 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. 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. 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.
Trial Locations
- Locations (1)
Cornerstone Medical Center
🇺🇸Centerville, Ohio, United States