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

Who is this study for? Patients with symptomatic hemorrhoids
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: f
View:

• between 21-90 years old

• presents with symptomatic haemorrhoids as evident from clinical assessment

• never had any haemorrhoid-related operations performed on them before

• fit for general anaesthesia

• able to give informed consent

• willing to be randomized

• willing to fill in post-operative questionnaires and be compliant to follow up

Locations
Other Locations
Singapore
Sengkang General Hospital
RECRUITING
Singapore
Contact Information
Primary
Fung Joon Foo
foo.fung.joon@singhealth.com.sg
+65 6930 5354
Backup
Fung Joon Foo
foo.fung.joon@singhealth.com.sg
+65 6930 6000
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 128
Treatments
Experimental: Laser Haemorrhoidoplasty (LAH)
treatment that we would like to study
Active_comparator: Conventional Open Haemorrhoidectomy (COH)
gold standard treatment as comparator
Related Therapeutic Areas
Sponsors
Collaborators: Biolitec
Leads: Sengkang General Hospital

This content was sourced from clinicaltrials.gov