N/A
N=90
A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01305473 ↗Enrolled (actual)
90
Serious AEs
3.3%
Results posted
Jul 2012
Primary outcome: Primary: Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. — 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. |
1 | — |
| SECONDARY Complications in Subjects With Hernias Repaired With Sepramesh. |
2 | — |
| SECONDARY Procedural Time for Sepramesh Placement. |
41.4 | — |
| SECONDARY Recovery Time Associated With Hernias Repaired With Sepramesh. |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01305473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.