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

Hernia Clinical Trial

— Sepramesh  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305473
• Other study ID #: DVL-HE007
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: July 31, 2012
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: July 2012
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Locations

Country	Name	City	State
United States	Cornerstone Medical Center	Centerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.	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.	12 months or greater (average follow-up time of 3 years; range 13-65 months)	No
Secondary	Complications in Subjects With Hernias Repaired With Sepramesh.	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).	12 months or greater (average follow-up time of 3 years; range 13-65 months)	Yes
Secondary	Procedural Time for Sepramesh Placement.	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).	Day 0	No
Secondary	Recovery Time Associated With Hernias Repaired With Sepramesh.	Recovery time will be defined as the time it took for the subject to return to work.	12 months or greater (average follow-up time of 3 years; range 13-65 months)	No