Clinical trial NCT01169311: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoid
Keywords: Hemorrhoids
Hemorrhoid
grade II, III, IV
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-07-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Uneventful Creation of a Functional Staple Line at First Firing of Device
timeFrame: about 20 minutes for procedure
Secondary outcomes:
measure: OR Time
timeFrame: Day 0 - Time of stop minus time of start
measure: Intra-Operative Bleeding Requiring Intervention
timeFrame: Day 0 - time of surgery
measure: Length of Stay
timeFrame: Day 0, time of discharge minus time of admission
measure: Time to Return to Normal Activity
timeFrame: 30 days post op
measure: Incidence of Stapler Malfunction or Misfires
timeFrame: about 20 minutes for procedure
measure: Post Operative Pain
timeFrame: baseline, 30 days post op
measure: Quality of Life, Physical Component
timeFrame: baseline, 30 days post op
measure: Quality of Life, Mental Component
timeFrame: Baseline, 30 days post op
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sang Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: