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

Not Applicable

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: Ligasure™ hemorrhoidectomy; Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).; Device: Ligasure Vessel Sealing; Device: THD anoscope and doppler

• Registration Number: NCT02654249
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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™.

Detailed 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2018-01
• Study Completion: 2020-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ligasure hemorroidectomy	Ligasure™ hemorrhoidectomy	Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
Ligasure hemorroidectomy	Ligasure Vessel Sealing	Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
THD and mucopexy	Transanal hemorrhoidal dearterialization + mucopexy (THD).	Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia.
THD and mucopexy	THD anoscope and doppler	Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	within the first 30 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	At 1 month and at 1 and 2 years after surgery	Quality of life by Short Form 12 (SF-12) Questionnaire
Specific disabilities (fecal incontinence and costipation)	At the day 15, 30 and at 1 and 2 years after surgery	Fecal incontinence by Vaizey Score and need of laxatives. Anorecatal manometry and endoanal ultrasonography will be performed two month after surgery.
Post-operative morbidity	within the first 30 days after surgery	Dindo classification of complicacions will be used
Hemorrhoid recurrence	At 1 and 2 years after surgery	rectal bleeding, anal pain, mucosal prolaps will be invastigated one year after hemorroidectomy. Needing of further surgery for hemorrhoids recurrence will be recorded
Satisfaction after surgery	At the day 15, 30 and at 1 and 2 years after surgery	A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.

Trial Locations

Locations (10)

Hospital Comarcal de Valdeorras; 🇪🇸 O Barco de Valdeorras, Ourense, Spain

Bellvitge University Hospital; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Rey Juan Carlos; 🇪🇸 Mostoles, Madrid, Spain

Galdakano Usansolo Hospital; 🇪🇸 Bizkaia, Pais Vasco, Spain

Valle d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario de la Ribera; 🇪🇸 Alzira, Valencia, Spain

Fundación Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Complejo Asistencial Universitario de Leon; 🇪🇸 Leon, Spain