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

Primary Purpose

Hemorrhoid

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemorrhoidopexy
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoid focused on measuring Hemorrhoids, Hemorrhoid, grade II, III, IV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HEEA Stapler

Arm Description

hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set

Outcomes

Primary Outcome Measures

Uneventful Creation of a Functional Staple Line at First Firing of Device
Successful creation of staple line at first firing of device during hemorrhoidopexy

Secondary Outcome Measures

OR Time
Duration of procedure
Intra-Operative Bleeding Requiring Intervention
Incidence of intervention for intra-operative staple-line bleeding
Length of Stay
length of time between time of admission and time of discharge
Time to Return to Normal Activity
Incidence of Stapler Malfunction or Misfires
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
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
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

Full Information

First Posted
July 22, 2010
Last Updated
September 30, 2014
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01169311
Brief Title
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
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 Im A Hemorrhoidopexy Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoid
Keywords
Hemorrhoids, Hemorrhoid, grade II, III, IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEEA Stapler
Arm Type
Experimental
Arm Description
hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set
Intervention Type
Device
Intervention Name(s)
Hemorrhoidopexy
Other Intervention Name(s)
Covidien EEA Hemorrhoid and Prolapse Stapling set
Primary Outcome Measure Information:
Title
Uneventful Creation of a Functional Staple Line at First Firing of Device
Description
Successful creation of staple line at first firing of device during hemorrhoidopexy
Time Frame
about 20 minutes for procedure
Secondary Outcome Measure Information:
Title
OR Time
Description
Duration of procedure
Time Frame
Day 0 - Time of stop minus time of start
Title
Intra-Operative Bleeding Requiring Intervention
Description
Incidence of intervention for intra-operative staple-line bleeding
Time Frame
Day 0 - time of surgery
Title
Length of Stay
Description
length of time between time of admission and time of discharge
Time Frame
Day 0, time of discharge minus time of admission
Title
Time to Return to Normal Activity
Time Frame
30 days post op
Title
Incidence of Stapler Malfunction or Misfires
Time Frame
about 20 minutes for procedure
Title
Post Operative Pain
Description
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
Title
Quality of Life, Physical Component
Description
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
Title
Quality of Life, Mental Component
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Lee, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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