Endoscopic band ligation versus injection sclerotherapy in patients with bleeding internal hemorrhoids: a prospective randomised study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To study the improvement in symptoms like bleeding, pain, prolapse.
研究概览
简要总结
| Title |
Endoscopic Band ligation versus injection sclerotherapy in patients with bleedinginternal hemorrhoids: a prospective randomised study.
|Objective
Primary objective- To compare the efficacy of Endoscopic band ligation and endoscopic Injection sclerotherapy procedures in patients with bleeding internal hemorrhoids.
Secondary objective- To test safety in terms of complications as a result of these procedures.
|Rationale
The rationale of this study is to compare the efficacy of two commonly used procedures for internal hemorrhoids. The results of this study will help clinicians in deciding which modality to use in patients presenting with bleeding internal hemorrhoids.
|Population
This prospective randomized controlled study will be done on patients presenting with rectal bleeding to the OPD/ IPD/ Emergency satisfying inclusion and exclusion criteria will be included.
|Design
This prospective randomized controlled study will be conducted at Fortis Hospital, Ludhiana from 1st July 2024 to 31st Dec, 2024. A total of 50 patients will be enrolled with 25 patients in each arm.
|Methodology
Patients presenting with symptoms will be screened for eligilibilty and informed written consent will be taken. Pre-procedural assessment with complete blood count, liver function tests, INR, TSH, HbA1c, and colonoscopy/sigmoidoscopy will be done on all the patients. Eligible patients as per inclusion criteria will be included in the trial and will be randomly allotted to one of the groups of RBL and IS procedure. Two arms: one with endoscopic band ligation, other with sclerotherapy using a sclerosant (polidochonol).
|Statistics
Data will be expressed as median and percentile values (5th, 25th, 75th and 95th percentiles). The upper limit of normal will be defined as the 95th percentile of expected values. P≤0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Symptomatic patients presenting with lower gastrointestinal bleed.
- •No age limit.
排除标准
- •Patients a known case or have previous history of chronic liver disease, liver cirrhosis, perianal or rectal surgery, anal fistula, perianal abscess, internal hemorrhoids infected or containing thrombi or inflammation, ulceration or gangrene, rectal or perianal malignancy, bleeding disorders, patients on antiplatelet or anticoagulant medications, pregnancy.
结局指标
主要结局
To study the improvement in symptoms like bleeding, pain, prolapse.
时间窗: three months
次要结局
- To study any adverse events with any of the procedure(three months)
研究者
Dr Neeraj Singla
First floor, Department of Gastroenterology, Fortis Hospital Ludhiana