Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

Study Overview
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Brief Summary
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Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction

Detailed Description
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Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort

Official Title
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Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy

Conditions
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Third Degree Hemorrhoids

Intervention / Treatment
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* Procedure: Hemorrhoidectomy
* Procedure: Hemorrhoidal dearterialization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids Exclusion Criteria: Previous anal surgery or pelvic radiotherapy Fecal incontinence or obstructed defecation IBD, IBS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Hemorrhoidectomy<br>Excision of hemorrhoid cushions | Procedure: Hemorrhoidectomy<br>* Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line<br>|
| Experimental: Hemorrhoidal dearterialization<br>Ligation of therminbal branches oh hemorrhoid arteries | Procedure: Hemorrhoidal dearterialization<br>* A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morbidity |  | 30 days | 
| resumption of working activity |  | 30 days | 
| patient's satisfaction |  | 30 days | 
| Relapse |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy