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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04329364
Other study ID # 2019/2930
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 1, 2020
Est. completion date June 30, 2025

Study information

Verified date April 2024
Source Sengkang General Hospital
Contact Fung Joon Foo
Phone +65 6930 5354
Email foo.fung.joon@singhealth.com.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Singapore Sengkang General Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
Sengkang General Hospital Biolitec

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Operative duration duration of operation during operation
Secondary Post-op bleeding incidence of bleeding post op 10 days from operation
Secondary readmission readmission due to complications 3 months
Secondary recurrence recurrence of haemorrhoids or symptoms 1 year post operation
Secondary 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
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