RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty

Study Overview
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Brief Summary
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Haemorrhoids or piles are the most common colorectal condition in the local population. Patients often present with bleeding with bowel movement or anal discomfort, both of which causes significant anxiety and stress. For symptomatic sizeable piles, the treatment of choice still remains the conventional open excision (COH). However, this technique carries with it a significant risk of bleeding and pain immediately after the operation, leading to some period of discomfort for the patients. The laser haemorrhoidoplasty procedure (LAH) has been shown in preliminary studies to have less pain, and less complications compared to COH. This study aims to directly compare these two techniques in a local Asian population. The investigators would be conducting a single-centre RCT simultaneously comparing the conventional open Milligan-Morgan haemorrhoidectomy (COH) and the laser haemorrhoidoplasty procedure (LAH) for the treatment of symptomatic grade ll-lV haemorrhoids. Primary outcomes will be post-operative pain while secondary outcomes include post-operative bleeding, readmission and/or reoperations, haemorrhoid-related quality of life (QoL) results and recurrence of symptoms up to a year post procedure

Official Title
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A Randomised Controlled Trial Comparing Conventional Open Haemorrhoidectomy and Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: COHLAH Trial

Conditions
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Hemorrhoids

Intervention / Treatment
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* Combination Product: Laser Haemorrhoidoplasty (LAH)
* Procedure: Open milligan-morgan conventional haemorrhoidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 21-90 years old presents with symptomatic haemorrhoids as evident from clinical assessment never had any haemorrhoid-related operations performed on them before fit for general anaesthesia able to give informed consent willing to be randomized willing to fill in post-operative questionnaires and be compliant to follow up Exclusion Criteria: Are pregnant Are prisoners Intellectually, mentally or emotionally deemed not able to provide an informed consent and/or are unable to fill up the post-procedure questionnaires/VAS score Have had previous haemorrhoid procedural treatment before (except Rubber Band Ligation) Declined endoscopic evaluation Are on anti-coagulation Have history of thrombophilia Are on steroids Have haemorrhoids which are incidentally found on endoscopy/clinical examination but are asymptomatic from it

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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
Interventional Model Description: The investigators would be conducting a single-centre RCT simultaneously comparing the conventional open Milligan-Morgan haemorrhoidectomy (COH) and the laser haemorrhoidoplasty procedure (LAH) for the treatment of symptomatic grade ll-lV haemorrhoids.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Haemorrhoidoplasty (LAH)<br>treatment that we would like to study | Combination Product: Laser Haemorrhoidoplasty (LAH)<br>* Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion<br>|
| Active Comparator: Conventional Open Haemorrhoidectomy (COH)<br>gold standard treatment as comparator | Procedure: Open milligan-morgan conventional haemorrhoidectomy<br>* conventional excisional haemorrhoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Daily visual analogue pain scale in the first 10 days after surgery. A score of 10 being the worst pain experienced and 1 being no pain experienced. | 10 days from op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative duration | duration of operation | during operation | 
| Post-op bleeding | incidence of bleeding post op | 10 days from operation | 
| readmission | readmission due to complications | 3 months | 
| recurrence | recurrence of haemorrhoids or symptoms | 1 year post operation | 
| Quality of Life measures | 2 validated questionnaires will be used ([patient self reported symptoms of haemorrhoids] Nystrom, et al. and [standardised haemorrhoidectomy QOL survey] Chew, et al) | 10 days, 1 month, 3 months and 1 year post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haemorrhoid, laser, haemorrhoidectomy