Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

January 31, 2018

Study Completion Date

January 31, 2020

Conditions
Hemorrhoids
Interventions
DEVICE

Transanal hemorrhoidal dearterialization + mucopexy (THD).

Using an anoscope combined with a Doppler transducer the hemorrhoidal arteries are identified and ligated to decrease the blood flow to the hemorrhoidal plexus. In order to reduce hemorroidal prolapse a mucopexy is performed.

PROCEDURE

Ligasure™ hemorrhoidectomy

Excisional hemorroidectomy performed with Ligasure™

DEVICE

THD anoscope and doppler

An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure

DEVICE

Ligasure Vessel Sealing

A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy

Trial Locations (10)

24071

Complejo Asistencial Universitario de Leon, León

28006

Hospital Universitario de La Princesa, Madrid

28040

Fundación Jimenez Diaz, Madrid

28046

Hospital La Paz, Madrid

28933

Hospital Universitario Rey Juan Carlos, Móstoles

32300

Hospital Comarcal de Valdeorras, O Barco de Valdeorras

46600

Hospital Universitario de la Ribera, Alzira

48960

Galdakano Usansolo Hospital, Bizkaia

08907

Bellvitge University Hospital, L'Hospitalet de Llobregat

08035

Valle d'Hebron University Hospital, Barcelona

All Listed Sponsors
lead

Hospital Universitari de Bellvitge

OTHER

NCT02654249 - Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids | Biotech Hunter | Biotech Hunter