Clinical trial NCT04329364: RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty
Official title: A Randomised Controlled Trial Comparing Conventional Open Haemorrhoidectomy and Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: COHLAH Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hemorrhoids
Keywords: haemorrhoid
laser
haemorrhoidectomy
Lead sponsor: Sengkang General Hospital
Sponsor class: OTHER
Collaborators: name: Biolitec
First posted: 2020-04-01
Enrollment: 128
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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


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

Primary outcomes:
measure: Pain scores
timeFrame: 10 days from op
Secondary outcomes:
measure: Operative duration
timeFrame: during operation
measure: Post-op bleeding
timeFrame: 10 days from operation
measure: readmission
timeFrame: 3 months
measure: recurrence
timeFrame: 1 year post operation
measure: Quality of Life measures
timeFrame: 10 days, 1 month, 3 months and 1 year post operation
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
References:
citation: 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.