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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
149
Surgical device
Surgical device
USF Tampa General Hospital Dept of Surgery
Tampa, Florida, United States
Intraoperative Bleeding
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.
Time frame: Day 0 - time of surgery
Post Operative Pain - (PI-NIRS)
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.
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 (Analgesic Intake)
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.
Time frame: Day 0, 1 week, 2 week, 1 month, 3 month, 6 month
Overall Quality of Life - General Health Score
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
Time frame: Day 0 minus 60, 1 week, 1 month, 3 months, 6 months
Location of the Staple Line
Distance of staple line to dentate line as measure by surgical ruler
Time frame: Day 0
Length of Stay
Length of hospital stay is defined as time of anoscope insertion until discharge
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Time frame: Day 0 time of discharge minus time of admission
Operative Room (OR) Time
Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Time frame: Day 0