Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Completed · Not applicable

Conditions studied: Hemorrhoids

In brief

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.

Key facts

Study ID

NCT01306877

Run by

Medtronic - MITG

People needed

149

Starts

2011-01-01

Expected to finish

2013-01-01

Last updated by the study team

2014-10-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• USF Tampa General Hospital Dept of Surgery — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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