Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Comparison of Boston Bowel Prep Score (BBPS)
研究概览
简要总结
The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.
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 (Investigator)
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
- •Consecutive adult patients (>18 years old) who require screening or surveillance colonoscopy
- •Ability to give consent
排除标准
- •Inability to obtain informed consent
- •Pregnant patients
- •Patients under the age of 18
- •Active ulcerative colitis or crohn's disease flare
- •Prisoners
研究组 & 干预措施
Isosmotic bowel cleansing preparation
Isosmotic solution ingested prior to colonoscopy
干预措施: Isosmotic bowel cleansing preparation (Other)
Colonic Hyrdrotherapy
Colonic hydrotherapy is an FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician.2 There
干预措施: Colonic Hyrdrotherapy (Other)
结局指标
主要结局
Comparison of Boston Bowel Prep Score (BBPS)
时间窗: 1 Day
Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)
次要结局
- Difference in the number of follow ups needed after colonoscopy(1 Day)
- Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)(1 Day)
- preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)(1 Day)
- Difference in Adenoma Detection Rate (ADR)(1 Day)