AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair: A Prospective, Randomized Comparison to Evaluate the Incidence of Post-operative Pain Associated With Absorbable Fixation (AbsorbaTack) vs Conventional Fixation (ProTack) Following Laparoscopic Hernia Repair|
- Postoperative Pain [ Time Frame: Discharge, Month 1, Month 6, Month 12 ] [ Designated as safety issue: No ]
Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.
Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".
- Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: Pre-op, Month 1, Month 6, 1 year ] [ Designated as safety issue: No ]
Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.
The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
- Hernia Recurrence [ Time Frame: Discharge, 1 Month, 6 Month, 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||November 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.
|Active Comparator: B||
Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749268
|United States, Ohio|
|University Hospitals at Case Medical Center|
|Cleveland, Ohio, United States, 44194|
|United States, South Carolina|
|Greenville Hospital System|
|Greenville, South Carolina, United States, 29605|
|Principal Investigator:||M Rosen||Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA|