Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids (NCT01306877) | Clinical Trial Compass
CompletedNot Applicable
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
United States149 participantsStarted 2011-01
Plain-language summary
The purpose of this study is to demonstrate that the Covidien EEAâ„¢ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
Who can participate
Age range18 Years – 85 Years
SexALL
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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.