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Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Bergamaschi, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01244672
First received: November 18, 2010
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Hemorrhoids
 Procedure: Ferguson
Procedure: THD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Post operative pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Patient reports pain levels at 14 days post surgery


Secondary Outcome Measures:
  • complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Complications involving hospital visit.


Enrollment: 40
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244672

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

No publications provided

Responsible Party: Roberto Bergamaschi, Professor and Chief, Division of colon and rectal surgery, Stony Brook University
ClinicalTrials.gov Identifier: NCT01244672     History of Changes
Other Study ID Numbers: 106946
Study First Received: November 18, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
Hemorrhoids
THD
Ferguson

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013