Comparing traditional and laser treatments for hemorrhoids
A Randomised Controlled Trial Comparing Conventional Open Haemorrhoidectomy and Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: COHLAH Trial
This study is testing whether traditional surgery or laser treatment is better for relieving pain and complications in people with moderate to severe hemorrhoids.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | Sengkang General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04329364 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of conventional open haemorrhoidectomy with laser haemorrhoidoplasty in treating symptomatic grade II-IV hemorrhoids. The study will involve patients aged 21 to 90 who have not undergone previous hemorrhoid surgeries and are fit for general anesthesia. Participants will be randomly assigned to receive either treatment, and their outcomes will be assessed through post-operative questionnaires. The goal is to determine which method results in less pain and fewer complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 90 with symptomatic hemorrhoids who have not had prior hemorrhoid surgeries.
Not a fit: Patients who are pregnant, have had previous hemorrhoid treatments, or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less painful and more effective treatment option for patients suffering from hemorrhoids.
How similar studies have performed: Preliminary studies have suggested that laser hemorrhoidoplasty may have advantages over conventional methods, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- Sengkang General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Fung Joon Foo
- Email: foo.fung.joon@singhealth.com.sg
- Phone: +65 6930 5354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.