Clinical Trial: Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon
Brief Summary: The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
Detailed Summary:
Sponsor: Medtronic - MITG
Current Primary Outcome: Intraoperative Bleeding [ Time Frame: Day 0 - time of surgery ]
Original Primary Outcome: Intraoperative Bleeding [ Time Frame: January 2011- March 2012 ]
Current Secondary Outcome:
- Post Operative Pain - (PI-NIRS) [ Time Frame: Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180 ]
Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.
The data represented is the change in baseline score at the different timepoints.
- Post-Operative Pain (Analgesic Intake) [ Time Frame: Day 0, 1 week, 2 week, 1 month, 3 month, 6 month ]post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.
- Overall Quality of Life - General Health Score [ Time Frame: Day 0 minus 60, 1 week, 1 month, 3 months, 6 months ]Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health
- Location of the Staple Line [ Time Frame: Day 0 ]Distance of staple line to dentate line as measure by surgical ruler
- Length of Stay [ Time Frame: Day 0 time of discharge minus time of admission ]Length of hospital stay is defined as time of anoscope insertion until discharge
- Operative Room (OR) Time [ Time Frame: Day 0 ]Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Original Secondary Outcome:
- Post operative pain. [ Time Frame: January 2011- March 2012 ]
- Overall quality of life. [ Time Frame: January 2011- Sept 2012 ]
- Location of the staple line. [ Time Frame: January 2011- March 2012 ]
- Safety. [ Time Frame: January 2011- Sept 2012 ]
- Length of stay. [ Time Frame: January 2011- March 2012 ]
- Operative Room (OR) time. [ Time Frame: January 2011- March 2012 ]
Information By: Medtronic - MITG
Dates:
Date Received: January 28, 2011
Date Started: January 2011
Date Completion:
Last Updated: October 24, 2014
Last Verified: October 2014