Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.

Official Title
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Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)

Conditions
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Hemorrhoids

Intervention / Treatment
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* Device: EEA Hemorrhoid and Prolapse Stapling Set
* Device: Endosurgery Proximate PPH03 Stapling Set


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is able to understand and sign Informed Consent Form The subject is between 18-85 years of age. The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy Exclusion Criteria: The procedure is needed as revision hemorrhoid surgery. Any female patient, who is pregnant, suspected pregnant, or nursing. 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 1 year 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 has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery. The participant has a history of fecal incontinence The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening 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: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEA Hemorrhoid and Prolapse Stapling Set<br> | Device: EEA Hemorrhoid and Prolapse Stapling Set<br>* Surgical device<br>|
| Active Comparator: Endosurgery Proximate PPH03 Stapling Set<br> | Device: Endosurgery Proximate PPH03 Stapling Set<br>* Surgical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Bleeding | Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow. | Day 0 - time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain - (PI-NIRS) | Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain. The data represented is the change in baseline score at the different timepoints. | Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180 | 
| Post-Operative Pain (Analgesic Intake) | post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study. | Day 0, 1 week, 2 week, 1 month, 3 month, 6 month | 
| Overall Quality of Life - General Health Score | Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health | Day 0 minus 60, 1 week, 1 month, 3 months, 6 months | 
| Location of the Staple Line | Distance of staple line to dentate line as measure by surgical ruler | Day 0 | 
| Length of Stay | Length of hospital stay is defined as time of anoscope insertion until discharge | Day 0 time of discharge minus time of admission | 
| Operative Room (OR) Time | Time of insertion of anoscope to time of anoscope removal after stapleline evaluation | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoid, hemorrhoid stapler