Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids (HEMOSTASIS)
|Hemorrhoids||Device: EEA Hemorrhoid and Prolapse Stapling Set Device: Endosurgery Proximate PPH03 Stapling Set|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)|
- 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.
- 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
|Study Start Date:||January 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: EEA Hemorrhoid and Prolapse Stapling Set||
Device: EEA Hemorrhoid and Prolapse Stapling Set
|Active Comparator: Endosurgery Proximate PPH03 Stapling Set||
Device: Endosurgery Proximate PPH03 Stapling Set
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306877
|United States, Florida|
|USF Tampa General Hospital Dept of Surgery|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Jorge Marcet, MD||University of South Florida|