Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effectiveness
研究概览
简要总结
This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.
详细描述
This study aims to evaluate the effectiveness of Oral Sodium Sulfate (OSS) in patients who have had poor colon preparation in the past. The study includes patients who had issues during their previous colonoscopy, such as needing extensive washing, inadequate preparation, a recommendation for shorter surveillance intervals, or adequate preparation for larger polyps but not smaller lesions.
Poor colon cleansing during a colonoscopy can lead to more prolonged procedures, lower polyp detection rates, and the need for repeat procedures with shorter surveillance intervals. OSS is a low-volume osmotic agent that causes diarrhea and colon cleansing by drawing water into the intestine. Health Canada and the FDA have approved it, and it is given in two 177ml bottles in a split dose. OSS is known for its good effect, ease of use, and tolerability, and it may be a better option than traditional cleansing agents.
All participants will receive OSS and instructions for use before their next surveillance colonoscopy. The study will use questionnaires and patient diaries to assess the effectiveness of OSS and patient compliance and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients Age 18 to 80 inclusive
- •Able to read and understand the English language
- •History of poor bowel prep defined as:
- •Required extensive washing, as noted in the narrative of the endoscopist report.
- •Inadequate preparation
- •Endoscopist recommended shorter interval surveillance due to poor prep
- •adequate for polyps >5mm but not smaller lesions
排除标准
- •Patients who have inflammatory bowel disease
- •Patients with ileus or bowel obstruction
- •Patients with history of colorectal resection
- •Patients receiving combined upper and lower endoscopies
- •Patients with ascites
- •Patients with previously documented severe renal impairment
- •Unable to provide consent
- •Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
- •Patients who have had a recent myocardial infarction(<6months)
研究组 & 干预措施
oral sodium sulfate
OSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine.
干预措施: oral sodium sulfate (Other)
结局指标
主要结局
Effectiveness
时间窗: 1-2 days
The primary outcome is proportion of patients with an adequate preparation (Boston preparation scale 6 or greater, with no section less than 2).
次要结局
未报告次要终点
研究者
Lawrence Charles Hookey
Professor
Queen's University