RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty (COHLAH)

Sengkang General Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hemorrhoids

Treatments: Procedure: Open milligan-morgan conventional haemorrhoidectomy; Combination Product: Laser Haemorrhoidoplasty (LAH)

Study type: Interventional

Funder types: Other

Identifiers

NCT04329364

2019/2930

Details and patient eligibility

About

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

Enrollment: 128 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. between 21-90 years old
2. presents with symptomatic haemorrhoids as evident from clinical assessment
3. never had any haemorrhoid-related operations performed on them before
4. fit for general anaesthesia
5. able to give informed consent
6. willing to be randomized
7. willing to fill in post-operative questionnaires and be compliant to follow up

Exclusion criteria

1. Are pregnant
2. Are prisoners
3. 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
4. Have had previous haemorrhoid procedural treatment before (except Rubber Band Ligation)
5. Declined endoscopic evaluation
6. Are on anti-coagulation
7. Have history of thrombophilia
8. Are on steroids
9. Have haemorrhoids which are incidentally found on endoscopy/clinical examination but are asymptomatic from it

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Laser Haemorrhoidoplasty (LAH)

Experimental group

Description:

treatment that we would like to study

Treatment:

Combination Product: Laser Haemorrhoidoplasty (LAH)

Conventional Open Haemorrhoidectomy (COH)

Active Comparator group

Description:

gold standard treatment as comparator

Treatment:

Procedure: Open milligan-morgan conventional haemorrhoidectomy