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 ]

Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.


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