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Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing two different strategies in the treatment of grade III and IV hemorrhoids: transanal hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.
Transanal hemorrhoidal dearterialization (THD) uses a specially developed anoscope combined with a Doppler transducer to identify the hemorrhoidal arteries. A suture ligation is performed to effectively decrease the blood flow to the hemorrhoidal plexus. In case of redundant prolapse, the prolapsed mucosa is lifted (mucopexy). THD procedure is performed without any incisions or removal of the hemorrhoidal tissue and moreover the suture line is above the dentate line, so post-operative pain and morbidities seem to be minimized in these patients. This technique differs from Ligasure hemorrhoidectomy, which focuses on excising the hemorrhoidal tissue. This prospective, randomized, multicenter and controlled trial compares post-operative pain, morbidities, quality of life, fecal incontinence and recurrence rate in patients treated for grade III and IV hemorrhoids with THD with mucopexy versus Ligasure hemorrhoidectomy.
Age
18 - 76 years
Sex
ALL
Healthy Volunteers
No
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Galdakano Usansolo Hospital
Bizkaia, Basque Country, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Comarcal de Valdeorras
O Barco de Valdeorras, Ourense, Spain
Hospital Universitario de la Ribera
Alzira, Valencia, Spain
Valle d'Hebron University Hospital
Barcelona, Spain
Complejo Asistencial Universitario de Leon
León, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Fundación Jimenez Diaz
Madrid, Spain
Hospital La Paz
Madrid, Spain
Start Date
December 1, 2015
Primary Completion Date
January 1, 2018
Completion Date
January 1, 2020
Last Updated
April 19, 2021
80
ACTUAL participants
Transanal hemorrhoidal dearterialization + mucopexy (THD).
DEVICE
Ligasure™ hemorrhoidectomy
PROCEDURE
THD anoscope and doppler
DEVICE
Ligasure Vessel Sealing
DEVICE
Lead Sponsor
Hospital Universitari de Bellvitge
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06660680