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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemorrhoids

Intervention / Treatment
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* Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).
* Procedure: Ligasure™ hemorrhoidectomy
* Device: THD anoscope and doppler
* Device: Ligasure Vessel Sealing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: THD and mucopexy<br>Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia. | Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).<br>* 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.<br>Device: THD anoscope and doppler<br>* An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure<br>|
| Active Comparator: Ligasure hemorroidectomy<br>Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia. | Procedure: Ligasure™ hemorrhoidectomy<br>* Excisional hemorroidectomy performed with Ligasure™<br>Device: Ligasure Vessel Sealing<br>* A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life by Short Form 12 (SF-12) Questionnaire | 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. | At the day 15, 30 and at 1 and 2 years after surgery | 
| Post-operative morbidity | Dindo classification of complicacions will be used | 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 | 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. | At the day 15, 30 and at 1 and 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids grade III and IV, transanal hemorrhoidal dearterialization, hemorroidectomy, THD, LigaSure