Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy

Not Applicable

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: THD; Procedure: Ferguson

• Registration Number: NCT01244672
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-anal dearterialization	THD	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
Ferguson	Ferguson	17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.

Primary Outcome Measures

Name	Time	Method
Post operative pain	14 days	Patient reports pain levels at 14 days post surgery

Secondary Outcome Measures

Name	Time	Method
complications	30 days	Complications involving hospital visit.

Trial Locations

Locations (1)

State University Hospital Medical Center; 🇺🇸 Stony Brook, New York, United States