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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemorrhoid

Intervention / Treatment
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* Device: Hemorrhoidopexy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEEA Stapler<br>hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set | Device: Hemorrhoidopexy<br> <br> * Other names: Covidien EEA Hemorrhoid and Prolapse Stapling set;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, Hemorrhoid, grade II, III, IV