A Phase 2/3 interventional study of Laser Haemorrhoidoplasty (LAH) and Open milligan-morgan conventional haemorrhoidectomy in Hemorrhoids, sponsored by Sengkang General Hospital. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Sengkang General Hospital · Phase 2/3, Interventional, and Treatment
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
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 128 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Sengkang General Hospital is the lead sponsor of 16 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment that we would like to study
Combination Product: Laser Haemorrhoidoplasty (LAH)
gold standard treatment as comparator
Procedure: Open milligan-morgan conventional haemorrhoidectomy
Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
conventional excisional haemorrhoidectomy
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.
Time frame: 10 days from op
Operative duration
duration of operation
Time frame: during operation
Post-op bleeding
incidence of bleeding post op
Time frame: 10 days from operation
readmission
readmission due to complications
Time frame: 3 months
recurrence
recurrence of haemorrhoids or symptoms
Time frame: 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)
Time frame: 10 days, 1 month, 3 months and 1 year post operation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — country's personal data protection Act restrictions clearance
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Sengkang General Hospital