Back to resultsTrans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy (THD)
Primary Purpose
Hemorrhoids
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferguson
THD
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoids, THD, Ferguson
Eligibility Criteria
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:
- physical exam
- anoscopy or proctoscopy
Exclusion Criteria:
- first and second degree hemorrhoids
- recurrent hemorrhoids after previous surgical treatment
- history of HIV
- history of inflammatory bowel disease
- inability to give informed consent due to mental disability
- age younger than 18
- history of colon, rectal or anal cancer
- thrombosed hemorrhoids
- pregnant women
- non English speaking patients
Sites / Locations
- State University Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Trans-anal dearterialization
Ferguson
Arm Description
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
17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.
Outcomes
Primary Outcome Measures
Post operative pain
Patient reports pain levels at 14 days post surgery
Secondary Outcome Measures
complications
Complications involving hospital visit.
Full Information
NCT ID
NCT01244672
First Posted
November 18, 2010
Last Updated
October 3, 2012
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT01244672
Brief Title
Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy
Acronym
THD
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
Hemorrhoids, THD, Ferguson
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans-anal dearterialization
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ferguson
Arm Type
Active Comparator
Arm Description
17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.
Intervention Type
Procedure
Intervention Name(s)
Ferguson
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
THD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post operative pain
Description
Patient reports pain levels at 14 days post surgery
Time Frame
14 days
Secondary Outcome Measure Information:
Title
complications
Description
Complications involving hospital visit.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
physical exam
anoscopy or proctoscopy
Exclusion Criteria:
first and second degree hemorrhoids
recurrent hemorrhoids after previous surgical treatment
history of HIV
history of inflammatory bowel disease
inability to give informed consent due to mental disability
age younger than 18
history of colon, rectal or anal cancer
thrombosed hemorrhoids
pregnant women
non English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
Organizational Affiliation
Stony Brook University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University Hospital Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy
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