Comparison of the Efficacy and Safety of Oral Sulfate Solution and 3-liter Polyethylene Glycol on Bowel Preparation Before Colonoscopy: a Multicenter Randomized Controlled Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 348
- 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 used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy
详细描述
Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG liquid is large and the taste of PEG is not good, so some patients could not take enough laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate, magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only tastes better, but also reduces the occurrence of electrolyte disturbances.
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
- Quadruple (Participant, 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;
- •Scheduling screening, surveillance, and diagnostic colonoscopy;
- •Necessary body fluid and blood electrolyte balance (the test values of potassium, sodium, chlorine, calcium and magnesium in blood biochemistry during screening period should not exceed 10% of the normal range).
排除标准
- •Subjects who used drugs that affect gastrointestinal dynamics, affect kidney function, or increase the risk of fluid retention or electrolyte disorders within 7 days before the start of the trial;
- •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 confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder or acute gastrointestinal bleeding;
- •Subjects with acute severe colitis (such as active severe inflammatory bowel disease, acute bacterial dysentery, diverticulitis, etc.);
- •Subjects with a history of major gastrointestinal surgery (e.g. gastric bypass, gastric septal surgery, colostomy, colectomy, etc.);
- •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
OSS group
Bowel preparation for colonoscopy was performed using oral sulfate solution as laxative
干预措施: Oral sulfate solution (OSS) (Drug)
Polyethylene glycol group
Bowel preparation for colonoscopy was performed using polyethylene glycol as laxative
干预措施: Polyethylene Glycol Electrolyte (Drug)
结局指标
主要结局
Bowel preparation adequate rate
时间窗: 30 minutes
Proportion of subjects with total Boston bowel preparation scale (BBPS) score (total colon) ≥6.
次要结局
- Colonoscopy completion rate(30 minutes)
- Boston bowel preparation scale (BBPS) score(30 minutes)
- Acceptability of laxatives by questionnaire survey(12 hours)
- Incidence of laxative-related adverse events assessed by clinical examinations(8 days)