Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy
NCT ID: NCT01244672
Last Updated: 2012-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-12-31
2012-09-30
Brief Summary
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Detailed Description
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In the standard surgical excision technique, the hemorrhoids are removed by cutting them out with a scalpel.
Both techniques are widely used in many hospitals today. However, there have been no formal studies comparing the two techniques regarding outcomes, particularly regarding pain after the procedure. We plan to enroll 60 patients in this study here at Stony Brook; 30 patients will have THD and 30 will have the standard surgical excision of hemorrhoids.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trans-anal dearterialization
24 patients were assigned to the Transanal hemorrhoidal dearterialization with mucopexy arm, which is a Doppler guided procedure for suture ligation of hemorrhidal arteries rather than excisional
THD
Transanal hemorrhoidal dearterialization will be performed using an endoscopic ultrasonic probe. Approximately 7-8 hemorrhoidal arteries will be ligated at 1, 3, 5, 7, 9, 11 o'clock position as previously described in the literature. The ligation will be performed using a vicryl suture. The ultrasonic probe locates the arterial signal.
Ferguson
17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.
Ferguson
This is a modification of the Milligan-Morgan technique, whereby the incisions are totally or partially closed with absorbable running suture. A retractor is used to expose the hemorrhoidal tissue, which is then removed surgically. The remaining tissue is either sutured or is sealed through the coagulation effects of a surgical device.
Interventions
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Ferguson
This is a modification of the Milligan-Morgan technique, whereby the incisions are totally or partially closed with absorbable running suture. A retractor is used to expose the hemorrhoidal tissue, which is then removed surgically. The remaining tissue is either sutured or is sealed through the coagulation effects of a surgical device.
THD
Transanal hemorrhoidal dearterialization will be performed using an endoscopic ultrasonic probe. Approximately 7-8 hemorrhoidal arteries will be ligated at 1, 3, 5, 7, 9, 11 o'clock position as previously described in the literature. The ligation will be performed using a vicryl suture. The ultrasonic probe locates the arterial signal.
Eligibility Criteria
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Inclusion Criteria
1. physical exam
2. anoscopy or proctoscopy
Exclusion Criteria
2. recurrent hemorrhoids after previous surgical treatment
3. history of HIV
4. history of inflammatory bowel disease
5. inability to give informed consent due to mental disability
6. age younger than 18
7. history of colon, rectal or anal cancer
8. thrombosed hemorrhoids
9. pregnant women
10. non English speaking patients
18 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Roberto Bergamaschi
Professor and Chief, Division of colon and rectal surgery
Principal Investigators
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Roberto Bergamaschi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University Medical Center
Locations
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State University Hospital Medical Center
Stony Brook, New York, United States
Countries
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Other Identifiers
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106946
Identifier Type: -
Identifier Source: org_study_id