Trial Objectives The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set: overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Weill Cornell Medical Center
New York, New York, United States
Uneventful Creation of a Functional Staple Line at First Firing of Device
Successful creation of staple line at first firing of device during hemorrhoidopexy
Time frame: about 20 minutes for procedure
OR Time
Duration of procedure
Time frame: Day 0 - Time of stop minus time of start
Intra-Operative Bleeding Requiring Intervention
Incidence of intervention for intra-operative staple-line bleeding
Time frame: Day 0 - time of surgery
Length of Stay
length of time between time of admission and time of discharge
Time frame: Day 0, time of discharge minus time of admission
Time to Return to Normal Activity
Time frame: 30 days post op
Incidence of Stapler Malfunction or Misfires
Time frame: about 20 minutes for procedure
Post Operative Pain
Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain
Time frame: baseline, 30 days post op
Quality of Life, Physical Component
Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation
Time frame: baseline, 30 days post op
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Quality of Life, Mental Component
quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation
Time frame: Baseline, 30 days post op