Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy (THD)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Post operative pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]Patient reports pain levels at 14 days post surgery
- complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]Complications involving hospital visit.
|Study Start Date:||December 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Trans-anal dearterialization
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
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.
Active Comparator: Ferguson
17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244672
|United States, New York|
|State University Hospital Medical Center|
|Stony Brook, New York, United States, 11794-8191|
|Principal Investigator:||Roberto Bergamaschi, MD, PhD||Stony Brook University Medical Center|