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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
Sponsor:
Collaborator:
Biolitec
Information provided by (Responsible Party):
Koh Hong Xiang Frederick, Sengkang General Hospital

Tracking Information
First Submitted Date  ICMJE March 19, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date April 22, 2024
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2020)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2020)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty
Official Title  ICMJE A Randomised Controlled Trial Comparing Conventional Open Haemorrhoidectomy and Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: COHLAH Trial
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Hemorrhoids
Intervention  ICMJE
  • Combination Product: Laser Haemorrhoidoplasty (LAH)
    Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
  • Procedure: Open milligan-morgan conventional haemorrhoidectomy
    conventional excisional haemorrhoidectomy
Study Arms  ICMJE
  • Experimental: Laser Haemorrhoidoplasty (LAH)
    treatment that we would like to study
    Intervention: Combination Product: Laser Haemorrhoidoplasty (LAH)
  • Active Comparator: Conventional Open Haemorrhoidectomy (COH)
    gold standard treatment as comparator
    Intervention: Procedure: Open milligan-morgan conventional haemorrhoidectomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2020)		 128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04329364
Other Study ID Numbers  ICMJE 2019/2930
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: country's personal data protection Act restrictions clearance
Current Responsible Party Koh Hong Xiang Frederick, Sengkang General Hospital
Original Responsible Party Koh Hong Xiang Frederick, Sengkang General Hospital, Senior Staff Registrar, Principal Investigator
Current Study Sponsor  ICMJE Sengkang General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Biolitec
Investigators  ICMJE Not Provided
PRS Account Sengkang General Hospital
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP