Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids

Study Overview
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Brief Summary
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Haemorrhoids have, in literature, extremely high ranges of prevalence, 4,4% to 36% and there is a debate on the best treatment for III degree hemorrhoids. The Stapled Hemorrhoidopexy is indicated in grade III haemorrhoids due to its advantages vs. other techniques in pain reduction and time before resume of normal activity. The new technique of Doppler guided trans-anal arterial ligation (THD) appear to be another important therapeutic tool thanks to its scarce complications, the minimally invasive procedure and efficacy of the short term results. The rationale of the two surgical techniques is different: in fact, the Stapled Hemorrhoidopexy is based on the hypothesis that the mucosal and sub/mucosal resection and stapling can cure the prolapse, etiologic factor of haemorrhoids; on the other hand, the interruption of the arterial inflow of hemorrhoids by THD reduces hemorrhoidal tissue. Aim of this study is to compare 2 techniques: The doppler guided transanal haemorrhoidal dearterialisation with the THD device and the stapled Haemorrhoidopexy (according to Longo) for III degree (Goligher) haemorrhoid, not regarding the number of prolapsed piles

Detailed Description
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After informed consent 284 patients with III degree hemorrhoids from 10 colorectal units will be randomized into two groups: stapler vs doppler guided transanal hemorrhoidal dearterialisation with the THD device.The early and long term outcome, as well as other secondary outcomes (costs, return to work and degree of satisfaction) will be recorded and compared.

Official Title
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Prospective Randomized Trial Comparing Transanal Doppler de-Arterialization (THD) Versus Stapler Operation for 3rd Degree Hemorrhoids

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: Transanal doppler hemorrhoidal ligation
* Procedure: stapled hemorrhoidopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: III degree hemorrhoids both sex age between 18 and 70 years ability to understand the procedure written informed consent Exclusion Criteria: previous surgery for hemorrhoids fecal incontinence obstructed defecation other active anorectic diseases irritable bowel syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: 1THD group<br>Series of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia | Procedure: Transanal doppler hemorrhoidal ligation<br>* THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy<br>* Other names: THD technique;|
| Active Comparator: 2 stapler group<br>135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy | Procedure: stapled hemorrhoidopexy<br>* Staple hemorrhoidopexy involves resection of a ring of low rectal mucosa an lifting the hemorrhoids up in the anal canal with a stapled suture<br>* Other names: Longo's technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early complication rate (bleeding, pain) and long term outcome (symptomatic hemorrhoids recurrence) after stapled hemorrhoidopexy versus transanal hemorrhoid arteries ligation and mucopexy |  | early postoperative period (30 days) and after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction |  | early postoperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoids, stapler, Doppler, artery ligation, outcome, recurrence