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

Sponsors

Lead Sponsor: Sengkang General Hospital

Collaborator: Biolitec

Source Sengkang General Hospital
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

Overall Status Recruiting
Start Date 2020-10-01
Completion Date 2022-12-31
Primary Completion Date 2022-12-31
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain scores 10 days from op
Secondary Outcome
Measure Time Frame
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
Enrollment 128
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: Laser Haemorrhoidoplasty (LAH)

Description: Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion

Arm Group Label: Laser Haemorrhoidoplasty (LAH)

Intervention Type: Procedure

Intervention Name: Open milligan-morgan conventional haemorrhoidectomy

Description: conventional excisional haemorrhoidectomy

Arm Group Label: Conventional Open Haemorrhoidectomy (COH)

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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Fung Joon Foo

Phone: +65 6930 5354

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Sengkang General Hospital Fung Joon Foo +65 6930 5354 [email protected] Frederick H Koh, FRCSEd Sub-Investigator Min-Hoe Chew, FRCSEd Sub-Investigator Winson Tan, FRCSEd Sub-Investigator Sharmini Sivarajah, FRCSEd Sub-Investigator Leonard Ho, FRCSEd Sub-Investigator Fung Joon Foo, FRCSEd Principal Investigator
Location Countries

Singapore

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sengkang General Hospital

Investigator Full Name: Koh Hong Xiang Frederick

Investigator Title: Associate Consultant, Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Laser Haemorrhoidoplasty (LAH)

Type: Experimental

Description: treatment that we would like to study

Label: Conventional Open Haemorrhoidectomy (COH)

Type: Active Comparator

Description: gold standard treatment as comparator

Acronym COHLAH
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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 Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking Description: 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.

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