RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty

Last updated: April 19, 2024
Sponsor: Sengkang General Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Hemorrhoids

Treatment

Laser Haemorrhoidoplasty (LAH)

Open milligan-morgan conventional haemorrhoidectomy

Clinical Study ID

NCT04329364
2019/2930
  • Ages 21-90
  • All Genders

Study 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

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

Exclusion Criteria:

  1. Are pregnant
  2. Are prisoners
  3. Intellectually, mentally or emotionally deemed not able to provide an informed consentand/or are unable to fill up the post-procedure questionnaires/VAS score
  4. Have had previous haemorrhoid procedural treatment before (except Rubber BandLigation)
  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 butare asymptomatic from it

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Laser Haemorrhoidoplasty (LAH)
Phase: 2/3
Study Start date:
October 01, 2020
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Sengkang General Hospital

    Singapore, 544886
    Singapore

    Active - Recruiting

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