RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty (COHLAH)
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ClinicalTrials.gov Identifier: NCT04329364 |
Recruitment Status :
Recruiting
First Posted : April 1, 2020
Last Update Posted : April 22, 2024
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhoids | Combination Product: Laser Haemorrhoidoplasty (LAH) Procedure: Open milligan-morgan conventional haemorrhoidectomy | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 128 participants |
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. |
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. |
Primary Purpose: | Treatment |
Official Title: | A Randomised Controlled Trial Comparing Conventional Open Haemorrhoidectomy and Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: COHLAH Trial |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | June 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Laser Haemorrhoidoplasty (LAH)
treatment that we would like to study
|
Combination Product: Laser Haemorrhoidoplasty (LAH)
Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion |
Active Comparator: Conventional Open Haemorrhoidectomy (COH)
gold standard treatment as comparator
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Procedure: Open milligan-morgan conventional haemorrhoidectomy
conventional excisional haemorrhoidectomy |
- Pain scores [ Time Frame: 10 days from op ]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.
- Operative duration [ Time Frame: during operation ]duration of operation
- Post-op bleeding [ Time Frame: 10 days from operation ]incidence of bleeding post op
- readmission [ Time Frame: 3 months ]readmission due to complications
- recurrence [ Time Frame: 1 year post operation ]recurrence of haemorrhoids or symptoms
- Quality of Life measures [ Time Frame: 10 days, 1 month, 3 months and 1 year post operation ]2 validated questionnaires will be used ([patient self reported symptoms of haemorrhoids] Nystrom, et al. and [standardised haemorrhoidectomy QOL survey] Chew, et al)
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Ages Eligible for Study: | 21 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Are pregnant
- Are prisoners
- 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
- Have had previous haemorrhoid procedural treatment before (except Rubber Band Ligation)
- Declined endoscopic evaluation
- Are on anti-coagulation
- Have history of thrombophilia
- Are on steroids
- Have haemorrhoids which are incidentally found on endoscopy/clinical examination but are asymptomatic from it
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329364
Contact: Fung Joon Foo | +65 6930 5354 | foo.fung.joon@singhealth.com.sg | |
Contact: Fung Joon Foo | +65 6930 6000 | foo.fung.joon@singhealth.com.sg |
Singapore | |
Sengkang General Hospital | Recruiting |
Singapore, Singapore, 544886 | |
Contact: Fung Joon Foo +65 6930 5354 foo.fung.joon@singhealth.com.sg | |
Sub-Investigator: 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 | |
Principal Investigator: Fung Joon Foo, FRCSEd |
Documents provided by Koh Hong Xiang Frederick, Sengkang General Hospital:
Responsible Party: | Koh Hong Xiang Frederick, Associate Consultant, Principal Investigator, Sengkang General Hospital |
ClinicalTrials.gov Identifier: | NCT04329364 |
Other Study ID Numbers: |
2019/2930 |
First Posted: | April 1, 2020 Key Record Dates |
Last Update Posted: | April 22, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | country's personal data protection Act restrictions clearance |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
haemorrhoid laser haemorrhoidectomy |
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Vascular Diseases Cardiovascular Diseases |