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RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty (COHLAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329364
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Biolitec
Information provided by (Responsible Party):
Koh Hong Xiang Frederick, 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


Condition or disease Intervention/treatment Phase
Hemorrhoids Combination Product: Laser Haemorrhoidoplasty (LAH) Procedure: Open milligan-morgan conventional haemorrhoidectomy Phase 2 Phase 3

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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 in a concealed opaque enveloped that is provided by the research administrator on the day of the operation. 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 : March 10, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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
Procedure: Open milligan-morgan conventional haemorrhoidectomy
conventional excisional haemorrhoidectomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Operative duration [ Time Frame: during operation ]
    duration of operation

  2. Post-op bleeding [ Time Frame: 10 days from operation ]
    incidence of bleeding post op

  3. readmission [ Time Frame: 3 months ]
    readmission due to complications

  4. recurrence [ Time Frame: 1 year post operation ]
    recurrence of haemorrhoids or symptoms

  5. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. between 21-70 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-platelets and/or 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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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         
Sponsors and Collaborators
Sengkang General Hospital
Biolitec
  Study Documents (Full-Text)

Documents provided by Koh Hong Xiang Frederick, Sengkang General Hospital:
Study Protocol  [PDF] March 7, 2020
Informed Consent Form  [PDF] February 29, 2020

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Responsible Party: Koh Hong Xiang Frederick, Senior Staff Registrar, 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 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: country's personal data protection Act restrictions clearance

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koh Hong Xiang Frederick, Sengkang General Hospital:
haemorrhoid
laser
haemorrhoidectomy
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases