Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

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)

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.

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.