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

Hemorrhoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169311
• Other study ID #: COVHEPH0021
• Status: Completed
• Phase: N/A
• First received: July 22, 2010
• Last updated: September 30, 2014
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hemorrhoid
• Hemorrhoids

Intervention

Device:
• Hemorrhoidopexy

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	OR Time	Duration of procedure	Day 0 - Time of stop minus time of start	No
Secondary	Intra-Operative Bleeding Requiring Intervention	Incidence of intervention for intra-operative staple-line bleeding	Day 0 - time of surgery	Yes
Secondary	Length of Stay	length of time between time of admission and time of discharge	Day 0, time of discharge minus time of admission	No
Secondary	Time to Return to Normal Activity		30 days post op	No
Secondary	Incidence of Stapler Malfunction or Misfires		about 20 minutes for procedure	No
Secondary	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	No
Secondary	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	No
Secondary	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	No