NCT04329364

RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Sengkang General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Laser Haemorrhoidoplasty (LAH)	Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
PROCEDURE	Open milligan-morgan conventional haemorrhoidectomy	conventional excisional haemorrhoidectomy

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2020-04-01
• Last updated: 2024-04-22

Locations

1 site across 1 country: Singapore