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| Name | Class |
|---|---|
| Biolitec Pharma Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Haemorrhoidoplasty (LAH) | Experimental | treatment that we would like to study |
|
| Conventional Open Haemorrhoidectomy (COH) | Active Comparator | gold standard treatment as comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Haemorrhoidoplasty (LAH) | Combination Product | Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | 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. | 10 days from op |
| Measure | Description | Time Frame |
|---|---|---|
| Operative duration | duration of operation | during operation |
| Post-op bleeding | incidence of bleeding post op | 10 days from operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fung Joon Foo | Contact | +65 6930 5354 | foo.fung.joon@singhealth.com.sg | |
| Fung Joon Foo | Contact | +65 6930 6000 | foo.fung.joon@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sengkang General Hospital | Recruiting | Singapore | 544886 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33631763 | Derived | 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. |
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country's personal data protection Act restrictions clearance
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2020 | Mar 19, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 29, 2020 | Mar 19, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.
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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.
| Open milligan-morgan conventional haemorrhoidectomy | Procedure | conventional excisional haemorrhoidectomy |
|
| readmission | readmission due to complications | 3 months |
| recurrence | recurrence of haemorrhoids or symptoms | 1 year post operation |
| Quality of Life measures | 2 validated questionnaires will be used ([patient self reported symptoms of haemorrhoids] Nystrom, et al. and [standardised haemorrhoidectomy QOL survey] Chew, et al) | 10 days, 1 month, 3 months and 1 year post operation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |