EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy

Status unconfirmed · Not applicable

Conditions studied: Hemorrhoids

In brief

This study will compare hemorrhoid surgery by comparing a sutureless heating device with the old standard hemorrhoid surgery. Patients will be followed closely for wound healing and satisfaction. Hypothesis: The sutureless device will be less painful for the patient and easier for the surgeon to perform.

Key facts

Study ID

NCT00853853

Run by

Steven Schechter, M.D.

People needed

100

Starts

2009-03-01

Expected to finish

2012-12-01

Last updated by the study team

2012-11-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men \& woman between ages 18-80.
• ASA level I, II, and III.
• External hemorrhoids may or may not be present.
• Internal hemorrhoids at least Grade II, III, and IV.

You may not qualify if…

• Age less than 18, or greater than 80.
• ASA level IV.
• Grade I internal hemorrhoids.
• Patients on Coumadin, Plavix, or other anticoagulant.
• Associated procedure such as sphincterotomy, drainage of abscess, fistulotomy, or the like.
• Pregnancy - Women who have a positive urine pregnancy test pre-op will be excluded from the study.
• Inflammatory bowel disease.
• History of chronic active hepatitis B, C, or HIV infection.
• Lactating women.
• Inability to follow up with surgeon in office at 1 week, 4 weeks, and 3 months postoperatively.
• Prior chronic narcotic use (> 30 days)

Where it is running

• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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