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

Hospital Universitari de Bellvitge80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemorrhoids

Interventions

Transanal hemorrhoidal dearterialization + mucopexy (THD).DEVICE

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.

Ligasure™ hemorrhoidectomyPROCEDURE

Excisional hemorroidectomy performed with Ligasure™

THD anoscope and dopplerDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

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.

Locations (10)

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, Spain

Galdakano Usansolo Hospital

Bizkaia, Basque Country, Spain

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: within the first 30 days after surgery

Secondary Outcomes

Quality of life

Quality of life by Short Form 12 (SF-12) Questionnaire

Time frame: At 1 month and at 1 and 2 years after surgery

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.

Time frame: At the day 15, 30 and at 1 and 2 years after surgery

Post-operative morbidity

Dindo classification of complicacions will be used

Time frame: within the first 30 days after surgery

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

Time frame: At 1 and 2 years after surgery

Satisfaction after surgery

A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.

Time frame: At the day 15, 30 and at 1 and 2 years after surgery

Data from ClinicalTrials.gov

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