RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty

Phase 2

Recruiting

• Conditions: Hemorrhoids
• Interventions: Combination Product: Laser Haemorrhoidoplasty (LAH); Procedure: Open milligan-morgan conventional haemorrhoidectomy

• Registration Number: NCT04329364
• Lead Sponsor: Sengkang General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-29
• Study First Posted: 2020-04-01
• Study Start: 2020-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Haemorrhoidoplasty (LAH)	Laser Haemorrhoidoplasty (LAH)	treatment that we would like to study
Conventional Open Haemorrhoidectomy (COH)	Open milligan-morgan conventional haemorrhoidectomy	gold standard treatment as comparator

Primary Outcome Measures

Name	Time	Method
Pain scores	10 days from op	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sengkang General Hospital; 🇸🇬 Singapore, Singapore