Hemorrhoids
Conditions
Keywords
haemorrhoid, laser, haemorrhoidectomy
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
Interventions
COMBINATION_PRODUCTLaser Haemorrhoidoplasty (LAH)
Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
PROCEDUREOpen milligan-morgan conventional haemorrhoidectomy
conventional excisional haemorrhoidectomy
Sponsors
Biolitec
Sengkang General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative duration | during operation | duration of operation |
| Post-op bleeding | 10 days from operation | incidence of bleeding post op |
| readmission | 3 months | readmission due to complications |
| recurrence | 1 year post operation | recurrence of haemorrhoids or symptoms |
| Quality of Life measures | 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) |
Countries
Singapore
Contacts
Primary ContactFung Joon Foo
Backup ContactFung Joon Foo
Outcome results
None listed