THD Versus Open Haemorrhoidectomy

Study Overview
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Brief Summary
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A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively. Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.

Official Title
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Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: Transanal Haemorrhoidal Dearterialization
* Procedure: Open Haemorrhoidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy The patient has a Haemorrhoidal Symptom Score of 4 or more The patient has an American Society of Anaesthesiologists (ASA) score I-II The patient's age is 18-85 years at inclusion The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion Exclusion Criteria: The patient has had previous operation for haemorrhoids within the last 2 years The patient has had previous operation for anal incontinence The patient has an active anal fistula The patient has an active anal fissure The patient has anal incontinence for solid stools

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Transanal Haemorrhoidal Dearterialization<br>Patients randomised to Transanal Haemorrhoidal Dearterialization. | Procedure: Transanal Haemorrhoidal Dearterialization<br> <br> * Other names: Hemorrhoidal Artery Ligation;|
| Active Comparator: Open Haemorrhoidectomy<br>Patients randomised to Open Haemorrhoidectomy | Procedure: Open Haemorrhoidectomy<br> <br> * Other names: Haemorrhoidectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemorrhoidal Symptoms | Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20. The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively. | 1-year and 5-years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain is registered using visual analog scale (VAS), by the hospital staff in the immediate postoperative course during hospital stay and by the patient the first 14 days postoperatively. | 14 days postoperatively | 
| Complications | Early and late complications are registered at 3 and 12 months and 5 years follow up. | 1-year and 5-years postoperatively | 
| Anal continence | Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months and 5 years postoperatively. | 1-year and 5-years postoperatively | 
| Quality of Life | QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively. | 1-year and 5-years postoperatively | 
| Health cost analysis | Health cost analysis will be based on an estimate of the cost of the operations, recovery of the patients and effect (need for further procedures or medical care). | 1-year and 5-years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, Haemorrhoids, Transanal Haemorrhoidal Dearterialization, Transanal Hemorrhoidal Dearterialisation, Open Haemorrhoidectomy, Open Hemorrhoidectomy