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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01169311
First received: July 22, 2010
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Hemorrhoid
Device: Hemorrhoidopexy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Uneventful Creation of a Functional Staple Line at First Firing of Device [ Time Frame: about 20 minutes for procedure ] [ Designated as safety issue: No ]
    Successful creation of staple line at first firing of device during hemorrhoidopexy


Secondary Outcome Measures:
  • OR Time [ Time Frame: Day 0 - Time of stop minus time of start ] [ Designated as safety issue: No ]
    Duration of procedure

  • Intra-Operative Bleeding Requiring Intervention [ Time Frame: Day 0 - time of surgery ] [ Designated as safety issue: Yes ]
    Incidence of intervention for intra-operative staple-line bleeding

  • Length of Stay [ Time Frame: Day 0, time of discharge minus time of admission ] [ Designated as safety issue: No ]
    length of time between time of admission and time of discharge

  • Time to Return to Normal Activity [ Time Frame: 30 days post op ] [ Designated as safety issue: No ]
  • Incidence of Stapler Malfunction or Misfires [ Time Frame: about 20 minutes for procedure ] [ Designated as safety issue: No ]
  • Post Operative Pain [ Time Frame: baseline, 30 days post op ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 27
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEEA Stapler
hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set
Device: Hemorrhoidopexy
Other Name: Covidien EEA Hemorrhoid and Prolapse Stapling set

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169311

Locations
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Sang Lee, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01169311     History of Changes
Other Study ID Numbers: COVHEPH0021
Study First Received: July 22, 2010
Results First Received: January 17, 2014
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
Hemorrhoids
Hemorrhoid
grade II, III, IV

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014