RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty

Hemorrhoids Clinical Trial

— COHLAH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04329364
• Other study ID #: 2019/2930
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Hemorrhoids

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