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

Hemorrhoids Clinical Trial

— THD-LIGA  

Official title:

Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654249
• Other study ID #: THD_LIGA_RCT
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 2020

Study information

• Verified date: April 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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™.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• Patients with grade III and IV hemorrhoids according to Goligher classification
• Patients ASA I, II or III and adequate hematological, renal and hepatic function
• Patients who signed informed consent

Exclusion Criteria:

• Altered cognitive state that prevents collaboration in the study or patients who can neither read nor write
• Fecal incontinence
• Anal sphincter lesions
• Recurrent hemorrhoids after previous surgical tratment
• Previous anorectal surgery except banding, botulinum toxin injection and thrombectomy for hemorrhoid thrombosis
• Injection sclerotherapy during the last five years
• Concomitant anorectal disease (anal fistula, anal fissure, anal stenosis, rectocele, enterocele, anal condilomatosis).
• Concomitant diagnosis of functional pelvic floor disease, inflammatory bowel disease and previous pelvic radiotherapy
• Concomitant diagnosis of colorectal neoplasia or other neoplasia
• Patients ASA IV, V
• NSAIDs, Paracetamol, Tramadol, Metamizol and Petidine allergy
• Coagulation disorders
• Pregnancy and lactation
• Rejection of the patient to sign the consent form.

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Ribera	Alzira	Valencia
Spain	Valle d'Hebron University Hospital	Barcelona
Spain	Galdakano Usansolo Hospital	Bizkaia	Pais Vasco
Spain	Bellvitge University Hospital	L'Hospitalet de Llobregat	Barcelona
Spain	Complejo Asistencial Universitario de Leon	Leon
Spain	Fundación Jimenez Diaz	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Mostoles	Madrid
Spain	Hospital Comarcal de Valdeorras	O Barco de Valdeorras	Ourense

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Post-operative pain by simple verbal numerical scale (0-10), the Andersen scale (0-5) and the taken pain medicacions will be recorded by the patients on a specific book during the first thirty days after surgery.	within the first 30 days after surgery
Secondary	Quality of life	Quality of life by Short Form 12 (SF-12) Questionnaire	At 1 month and at 1 and 2 years after surgery
Secondary	Specific disabilities (fecal incontinence and costipation)	Fecal incontinence by Vaizey Score and need of laxatives. Anorecatal manometry and endoanal ultrasonography will be performed two month after surgery.	At the day 15, 30 and at 1 and 2 years after surgery
Secondary	Post-operative morbidity	Dindo classification of complicacions will be used	within the first 30 days after surgery
Secondary	Hemorrhoid recurrence	rectal bleeding, anal pain, mucosal prolaps will be invastigated one year after hemorroidectomy. Needing of further surgery for hemorrhoids recurrence will be recorded	At 1 and 2 years after surgery
Secondary	Satisfaction after surgery	A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.	At the day 15, 30 and at 1 and 2 years after surgery