Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques

Stopped early · Not applicable

Conditions studied: Hemorrhoids

In brief

The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques. It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.

Key facts

Study ID

NCT01422473

Run by

Swedish Medical Center

People needed

9

Starts

2011-08-01

Expected to finish

2013-01-01

Last updated by the study team

2013-06-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between ages 18 through 80
• American Society of Anesthesiologists (ASA) level I, II and III
• External hemorrhoids must be present and deemed sufficiently symptomatic to warrant removal
• Internal hemorrhoids at least Grade II
• Must be able to be seen post-operatively by the surgeon at 3 to 4 weeks and 3 months after surgery

You may not qualify if…

• American Society of Anesthesiologists (ASA) level IV
• Grade I internal hemorrhoids
• Currently receiving coumadin, plavix, or other anticoagulants
• No prior sphincterotomy, drainage of abscess, fistulotomy, or similar procedures
• No pregnant women at the time of surgery
• No lactating women
• No inflammatory bowel disease
• No history of chronic, active hepatitis B, C, or HIV infection
• No prior chronic narcotic use (more than 30 days)

Where it is running

• Swedish Medical Center Colon Rectal Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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