Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy

Hemorrhoids Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244672
• Other study ID #: 106946
• Status: Completed
• Phase: N/A
• First received: November 18, 2010
• Last updated: October 3, 2012
• Start date: December 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	State University Hospital Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Patient reports pain levels at 14 days post surgery	14 days	No
Secondary	complications	Complications involving hospital visit.	30 days	No