Clinical Trial: Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology I
Brief Summary:
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.
Detailed Summary:
Sponsor: Medtronic - MITG
Current Primary Outcome: Uneventful Creation of a Functional Staple Line at First Firing of Device [ Time Frame: about 20 minutes for procedure ]
Original Primary Outcome: Safety and Efficacy [ Time Frame: 30 days ]
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.
Current Secondary Outcome:
- OR Time [ Time Frame: Day 0 - Time of stop minus time of start ]Duration of procedure
- Intra-Operative Bleeding Requiring Intervention [ Time Frame: Day 0 - time of surgery ]Incidence of intervention for intra-operative staple-line bleeding
- Length of Stay [ Time Frame: Day 0, time of discharge minus time of admission ]length of time between time of admission and time of discharge
- 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 [ Time Frame: baseline, 30 days post op ]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
- Quality of Life, Physical Component [ Time Frame: baseline, 30 days post op ]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
- Quality of Life, Mental Component [ Time Frame: Baseline, 30 days post op ]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
Original Secondary Outcome:
Information By: Medtronic - MITG
Dates:
Date Received: July 22, 2010
Date Started: July 2010
Date Completion:
Last Updated: September 30, 2014
Last Verified: September 2014