Rubber Band Ligation Versus Laser Haemorrhoidoplasty : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Resolution of symptoms (rectal bleeding, discomfort, itching, mucous discharge), determined by direct or telephonic interview of patients at three months after RBL or LH
研究概览
简要总结
Internal hemorrhoids are dilated vascular cushions above the dentate line. Internal hemorrhoids can lead to a clinical spectrum of symptoms ranging from bleeding PR, perianal discomfort and itching, constipation, and many more. Currently, a number of treatment modalities exist for the treatment including conservative management, rubber band ligation, open surgeries, etc., with the current gold standard being rubber band ligation for grade 1 to 3 internal hemorrhoids. In this study, we aim to compare the current gold standard with the newer modality that is laser hemorrhoidoplasty for grade 2 and grade 3 hemorrhoids. It uses laser fiber of argon laser fiber of wavelength 1470 nanometer. Preoperatively, the patient is examined to locate the hemorrhoids and intraoperatively laser pulses are given which results in reduced vascular flow and fibrosis in the long term, thus reducing the size of the pile mass and causing symptomatic relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •Adult patients aged 18 to 70 years
- •Grade II and III internal haemorrhoids.
排除标准
- •Exclusion criteria
- •Circumferential haemorrhoids or haemorrhoids in all 3, 7 and 11 o’ clock positions
- •Patients on anticoagulant and antiplatelet agents
- •Patients developing haemorrhoids secondary to portal hypertension
- •Patients who have undergone previous procedure for haemorrhoids
- •Presence of other associated perianal pathology including anal stenosis, anal fissure, fistula or anorectal tumors.
- •Patients on opioids or any substance abuse
- •Immunocompromised patients.
- •Known HIV/ AIDS, patients on immunosuppressive drugs including steroids
- •Previous surgical anastomosis less than 3 cm from dentate line
- •Patients with inflammatory bowel disease
- •Fecal incontinence
- •Obstructed defecation syndrome
- •Irritable bowel syndrome with severe constipation or diarrhoea symptoms.
结局指标
主要结局
Resolution of symptoms (rectal bleeding, discomfort, itching, mucous discharge), determined by direct or telephonic interview of patients at three months after RBL or LH
时间窗: 24 hours, 1 week, 2 weeks, 3 months
次要结局
- 1. Incidence of pain at 24 hours, 1 week, 2 weeks and 3 months, measured by Numerical Pain Rating Scale, on a scale of 0 to 10, where 0 is no pain and 10 is maximum possible pain(2. Procedure time, measured in minutes)
研究者
Dr Nalamwad Durgeshwari Balaji
AIIMS New Delhi