RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty (COHLAH)

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

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

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Combination product: Laser Haemorrhoidoplasty (LAH); Procedure: Open milligan-morgan conventional haemorrhoidectomy

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Fung Joon Foo; Phone Number: +65 6930 5354; Email: foo.fung.joon@singhealth.com.sg
• Study Contact Backup: Name: Fung Joon Foo; Phone Number: +65 6930 6000; Email: foo.fung.joon@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 544886
    • Recruiting
    • Sengkang General Hospital
    • Contact: Fung Joon Foo; Phone Number: +65 6930 5354; Email: foo.fung.joon@singhealth.com.sg
    • Sub-Investigator: Frederick H Koh, FRCSEd
    • Sub-Investigator: Min-Hoe Chew, FRCSEd
    • Sub-Investigator: Winson Tan, FRCSEd
    • Sub-Investigator: Sharmini Sivarajah, FRCSEd
    • Sub-Investigator: Leonard Ho, FRCSEd
    • Principal Investigator: Fung Joon Foo, FRCSEd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sengkang General Hospital
• Collaborators: Biolitec

Publications and helpful links

General Publications

• Koh FH, Foo FJ, Ho L, Sivarajah SS, Tan WJ, Chew MH. Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial. Eur Surg Res. 2020;61(6):201-208. doi: 10.1159/000513844. Epub 2021 Feb 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 29, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laser; haemorrhoid; haemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 2019/2930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: country's personal data protection Act restrictions clearance

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No