Clinical trial

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

Name
2019/2930
Description
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 arms
Trial start
2020-10-01
Estimated PCD
2024-12-31
Trial end
2025-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Laser Haemorrhoidoplasty (LAH)
Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
Arms:
Laser Haemorrhoidoplasty (LAH)
Open milligan-morgan conventional haemorrhoidectomy
conventional excisional haemorrhoidectomy
Arms:
Conventional Open Haemorrhoidectomy (COH)
Size
128
Primary endpoint
Pain scores
10 days from op
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.\n\nAn 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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}
Updated at
2024-04-22

1 organization

1 product

1 indication

Indication
Hemorrhoids