Evaluating the Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution: A Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Bowel preparation adequate rate
研究概览
简要总结
To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality.
详细描述
The split-dose bowel preparation is recommended by multiple guidelines and widely used worldwide for improved bowel preparation quality, higher detection rate of colorectal lesions, and better tolerance. The effect of the time interval between the last dose of laxative and the colonoscopy on the quality of bowel preparation has been well studied, but the impact of the time interval between the first and last dose of laxative on the bowel preparation quality deserve to be explored. Oral sulfate solution administered in a short time interval can reduce sleep disturbance and hunger and is more flexible and convenient. This study aims to evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) is not inferior to a long time interval (10-12 hours) on bowel preparation quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily participate and sign informed consent;
- •Subjects who require screening, surveillance, and diagnostic colonoscopy;
- •Subjects who take the oral sulfate solution for bowel preparation.
排除标准
- •Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, renal or liver dysfunction;
- •Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration.
- •Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding;
- •Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon.
- •Subjects who had previously undergone colorectal resection.
- •Subjects with constipation or suspected severe gastric motility disorder;
- •Women with positive pregnancy tests or pregnancy plans, and women in lactation;
- •Subjects who have participated in any other clinical trials within the last 3 months;
- •Subjects with any other conditions that the investigator considered inappropriate for inclusion.
研究组 & 干预措施
Short time interval group:
Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative
干预措施: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution (Drug)
Standard time interval group
Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative
干预措施: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution (Drug)
结局指标
主要结局
Bowel preparation adequate rate
时间窗: 30minutes
Adequate bowel cleansing was defined as a total Boston Bowel Preparation Scale (BBPS) ≥ 6 with a partial BBPS ≥ 2 in each colon segment.
次要结局
- Acceptability of bowel preparation by questionnaire survey(12 hours)