Single-blinded Randomized Trial of Latex vs Non-latex Hemorrhoid Banding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Hemorrhoid Band Efficacy
研究概览
简要总结
This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our goal will be to measure the performance of latex bands vs non-latex bands.
详细描述
This study will involve the recruitment of adult patients with symptomatic grade 2-3 internal hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our hypothesis is that non-latex hemorrhoidal bands are non-inferior to latex bands for the treatment of grade 2-3 internal hemorrhoids.
The secondary objective of the study is to compare banding-related adverse effects including pain, bleeding, and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation
排除标准
- •Previous hemorrhoidal banding within the past year
- •Known latex allergy
- •Pregnancy
- •Anticoagulation use
- •Bleeding disorder
- •Portal hypertension
- •Inflammatory bowel disease
- •Immunosuppression
- •Functional neurologic disorder
- •Pelvic floor dysfunction
- •Any records flagged "break the glass" or "research opt out".
研究组 & 干预措施
Latex band
latex bands will be placed on hemorrhoids during banding
干预措施: Latex Band (Device)
Non-latex band
Non-latex bands will be placed on hemorrhoids during banding
干预措施: Non-Latex Band (Device)
结局指标
主要结局
Hemorrhoid Band Efficacy
时间窗: 2-4 months
hemorrhoidal bleeding and prolapse symptoms following ligation.
次要结局
- Banding-related Adverse events(2-4 months)
研究者
Adam Truong
Investigator
Huntington Memorial Hospital