Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy for 3rd and 4th Degree Hemorrhoids in at Least Three Quadrants: A Prospective Randomized Control Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stony Brook University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Post operative pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
Outcomes
Primary Outcomes
Post operative pain
Time Frame: 14 days
Patient reports pain levels at 14 days post surgery
Secondary Outcomes
- complications(30 days)
Investigators
Roberto Bergamaschi
Professor and Chief, Division of colon and rectal surgery
Stony Brook University