Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

Not Applicable

Completed

• Conditions: Hemorrhoid
• Interventions: Device: Hemorrhoidopexy

• Registration Number: NCT01169311
• Lead Sponsor: Medtronic - MITG

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 Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Results First Submitted: 2014-01-17
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Results First Posted: 2014-10-06
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Able to understand and sign Informed Consent Form
• The participant must be 18-80 years of age.
• The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

Exclusion Criteria

• The procedure is needed as revision hemorrhoid surgery.
• The participant is pregnant.
• The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
• The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
• The participant has a history of drug or alcohol abuse.
• The participant has a history of venous thrombosis or pulmonary embolism.
• The participant has a history of coagulopathy.
• The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
• The participant has a history of fecal incontinence.
• The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HEEA Stapler	Hemorrhoidopexy	hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set

Primary Outcome Measures

Name	Time	Method
Uneventful Creation of a Functional Staple Line at First Firing of Device	about 20 minutes for procedure	Successful creation of staple line at first firing of device during hemorrhoidopexy

Secondary Outcome Measures

Name	Time	Method
Intra-Operative Bleeding Requiring Intervention	Day 0 - time of surgery	Incidence of intervention for intra-operative staple-line bleeding
Post Operative Pain	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
Length of Stay	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	30 days post op
OR Time	Day 0 - Time of stop minus time of start	Duration of procedure
Quality of Life, Physical Component	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
Incidence of Stapler Malfunction or Misfires	about 20 minutes for procedure
Quality of Life, Mental Component	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

Trial Locations

Locations (1)

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States