Hemorrhoids
Conditions
Keywords
Hemorrhoids, THD, Ferguson
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.
Interventions
PROCEDUREFerguson
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.
PROCEDURETHD
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.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain | 14 days | Patient reports pain levels at 14 days post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications | 30 days | Complications involving hospital visit. |
Countries
United States
Outcome results
None listed