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OpenTrials
Completed

NCT Number: NCT01244672

Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy

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

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University Hospital Medical Center

Stony Brook, New York, 11794-8191, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferguson

Procedure

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

Procedure

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 outcomes

  1. Post operative pain

    Time frame: 14 days

    Patient reports pain levels at 14 days post surgery

Secondary outcomes

  1. complications

    Time frame: 30 days

    Complications involving hospital visit.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study 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.

Acronym: THD

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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