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

A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure

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 Overview

• Status: Completed
• Conditions: Hemorrhoid
• Intervention / Treatment: Device: Hemorrhoidopexy

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEEA Stapler; hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set	Device: Hemorrhoidopexy; Other Names: Covidien EEA Hemorrhoid and Prolapse Stapling set

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OR Time	Duration of procedure	Day 0 - Time of stop minus time of start
Intra-Operative Bleeding Requiring Intervention	Incidence of intervention for intra-operative staple-line bleeding	Day 0 - time of surgery
Length of Stay	length of time between time of admission and time of discharge	Day 0, time of discharge minus time of admission
Time to Return to Normal Activity		30 days post op
Incidence of Stapler Malfunction or Misfires		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	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	baseline, 30 days post op
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	Baseline, 30 days post op

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Sang Lee, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (Estimate): July 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 6, 2014
• Last Update Submitted That Met QC Criteria: September 30, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Hemorrhoids; Hemorrhoid; grade II, III, IV
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Prolapse; Hemorrhoids
• Other Study ID Numbers: COVHEPH0021