Status:
UNKNOWN
EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy
Lead Sponsor:
Steven Schechter, M.D.
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Hemorrhoids
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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. Hyp...
Detailed Description
The EnSeal Device is approved for laparoscopic surgery in ligating and dividing vascular tissue during abdominal surgery. Electrical energy is converted into heat energy and resultant simultaneous div...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00853853
Start Date
March 1 2009
End Date
December 1 2012
Last Update
November 20 2012
Active Locations (1)
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1
The Miriam Hospital
Providence, Rhode Island, United States, 02906