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Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy (THD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244672
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : October 5, 2012
Information provided by (Responsible Party):
Roberto Bergamaschi, Stony Brook University

Brief Summary:
The purpose of this study is to compare the frequency and severity of postoperative( after surgery) pain between two surgical techniques for treating severe hemorrhoids. The two techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical excision (removal) of the hemorrhoids

Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Ferguson Procedure: THD Not Applicable

Detailed Description:

The THD technique involves using ultrasound equipment to identify the arteries that are feeding blood into the hemorrhoids. Once located, stitches are placed around those arteries to cut off the blood supply to the hemorrhoids, which destroys them.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy for 3rd and 4th Degree Hemorrhoids in at Least Three Quadrants: A Prospective Randomized Control Pilot Study.
Study Start Date : December 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Active Comparator: 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
Procedure: 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.

Active Comparator: Ferguson
17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.
Procedure: 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.

Primary Outcome Measures :
  1. Post operative pain [ Time Frame: 14 days ]
    Patient reports pain levels at 14 days post surgery

Secondary Outcome Measures :
  1. complications [ Time Frame: 30 days ]
    Complications involving hospital visit.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients visiting colorectal outpatient office at Stony Book Medical Center, with the diagnosis of 3rd or 4th degree hemorrhoids requiring hemorrhoidectomy will be invited to participate in this study. The diagnosis of hemorrhoids will be established by a colorectal surgeon based on following criteria:

  1. physical exam
  2. anoscopy or proctoscopy

Exclusion Criteria:

  1. first and second degree hemorrhoids
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01244672

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United States, New York
State University Hospital Medical Center
Stony Brook, New York, United States, 11794-8191
Sponsors and Collaborators
Stony Brook University
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Principal Investigator: Roberto Bergamaschi, MD, PhD Stony Brook University Medical Center

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Responsible Party: Roberto Bergamaschi, Professor and Chief, Division of colon and rectal surgery, Stony Brook University Identifier: NCT01244672    
Other Study ID Numbers: 106946
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012
Keywords provided by Roberto Bergamaschi, Stony Brook University:
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases