Clinical Trial: Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Brief Summary: This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.

Detailed Summary:
Sponsor: C. R. Bard

Current Primary Outcome: The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. [ Time Frame: 1 year post surgery ]

A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.


Original Primary Outcome: The primary endpoint is the rate of hernia recurrence in study subjects. A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure. [ Time Frame: 1 year post surgery ]

Current Secondary Outcome:

  • Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. [ Time Frame: From the time of surgery to hospital discharge, an average of 1-2 days ]
    In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
  • Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. [ Time Frame: Hospital discharge through 21 days post surgery ]
    In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
  • Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. [ Time Frame: 22 days post surgery through 1 year post surgery ]
    In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
  • Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey [ Time Frame: Baseline and post-surgery at week 2, month 6 and month 12 ]
    Mean Quality of Life scores at each study visit for the "sensation of mesh," "pain," and "movement limitation" components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure.
  • Procedure Time [ Time Frame: Day of surgery ]
    Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.


Original Secondary Outcome:

  • Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. [ Time Frame: From the time of surgery to hospital discharge. ]
  • Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. [ Time Frame: 21 days post surgery ]
  • Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. [ Time Frame: 1 year post surgery ]
  • Changes in QOL will be assessed from baseline to 1 year utilizing the Carolinas Comfort Scale survey. [ Time Frame: 1 year post surgery ]
  • Procedure Time Will be Defined as Beginning When the Investigator Makes the Initial Incision and Ending When the Skin Closure is Completed. [ Time Frame: Day of surgery ]


Information By: C. R. Bard

Dates:
Date Received: March 20, 2009
Date Started: March 2009
Date Completion:
Last Updated: October 10, 2012
Last Verified: October 2012