Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bowel cleansing
研究概览
简要总结
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.
详细描述
Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 18y and 90y
- •Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy
排除标准
- •Patients <18y or >90y
- •Pregnant Women
- •Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study
- •Patients with a history of bowel resection
- •Patients undergoing therapeutic colonoscopy
- •Patients unable to understand study protocol
研究组 & 干预措施
1L PEG
干预措施: Endoscopy (Procedure)
2L PEG
干预措施: Endoscopy (Procedure)
2L sodium picosulfate
干预措施: Endoscopy (Procedure)
结局指标
主要结局
Bowel cleansing
时间窗: 1 year
Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.
次要结局
- Treatment related adverse events(1 year)
- Preparation Tolerability: total volume of solution finally taken by the patient(1 year)
研究者
María Dolores Martín Arranz, PhD
Principal Investigator
Hospital Universitario La Paz