A Randomised Controlled Trial Comparing Conventional Open Haemorrhoidectomy and Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: COHLAH Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Pain scores
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 21-90 years old
- •presents with symptomatic haemorrhoids as evident from clinical assessment
- •never had any haemorrhoid-related operations performed on them before
- •fit for general anaesthesia
- •able to give informed consent
- •willing to be randomized
- •willing to fill in post-operative questionnaires and be compliant to follow up
排除标准
- •Are pregnant
- •Are prisoners
- •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
- •Have had previous haemorrhoid procedural treatment before (except Rubber Band Ligation)
- •Declined endoscopic evaluation
- •Are on anti-coagulation
- •Have history of thrombophilia
- •Are on steroids
- •Have haemorrhoids which are incidentally found on endoscopy/clinical examination but are asymptomatic from it
结局指标
主要结局
Pain scores
时间窗: 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.
次要结局
- Operative duration(during operation)
- Post-op bleeding(10 days from operation)
- readmission(3 months)
- recurrence(1 year post operation)
- Quality of Life measures(10 days, 1 month, 3 months and 1 year post operation)
研究者
Koh Hong Xiang Frederick
Associate Consultant, Principal Investigator
Sengkang General Hospital