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
1 other identifier
interventional
128
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedApril 22, 2024
April 1, 2024
4.3 years
March 19, 2020
April 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Operative duration
during operation
Post-op bleeding
10 days from operation
readmission
3 months
recurrence
1 year post operation
Quality of Life measures
10 days, 1 month, 3 months and 1 year post operation
Study Arms (2)
Laser Haemorrhoidoplasty (LAH)
EXPERIMENTALtreatment that we would like to study
Conventional Open Haemorrhoidectomy (COH)
ACTIVE COMPARATORgold standard treatment as comparator
Interventions
Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
conventional excisional haemorrhoidectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sengkang General Hospitallead
- Bioliteccollaborator
Study Sites (1)
Sengkang General Hospital
Singapore, 544886, Singapore
Related Publications (1)
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.
PMID: 33631763DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Allocation is provided through calling the study administrator at time of Examination under Anaesthesia. Thus, the participant is blinded to the procedure. There will also be no cross-over from one study arm to another. An independent research administrator, not part of the randomisation process, will also contact the patient 3 months and 1 year after the procedure as mentioned above.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant, Principal Investigator
Study Record Dates
First Submitted
March 19, 2020
First Posted
April 1, 2020
Study Start
October 1, 2020
Primary Completion
December 31, 2024
Study Completion
June 30, 2025
Last Updated
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
country's personal data protection Act restrictions clearance