Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy

Stony Brook University40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemorrhoids

Interventions

FergusonPROCEDURE

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.

THDPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

State University Hospital Medical Center

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Post operative pain

Patient reports pain levels at 14 days post surgery

Time frame: 14 days

Secondary Outcomes

complications

Complications involving hospital visit.

Time frame: 30 days

Data from ClinicalTrials.gov

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