A Single-center, Single-blind, Randomized Controlled Clinical Study of Bowel Preparation Before Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- BBPS
研究概览
简要总结
This study was a single-center, randomized controlled clinical study. Subjects meeting the inclusion criteria will be randomly assigned to magnesium sodium potassium sulfate oral concentrated solution group, magnesium sodium potassium sulfate oral concentrated solution + linaclotide group, PEG group in equal proportion.
详细描述
Research purpose
In this study, by evaluating patients' intestinal cleanliness rate (BBPS score) and quantitative analysis of intestinal bubble under colonoscopy, three intestinal preparation schemes were respectively investigated: The effectiveness, tolerability, adverse reactions and prognosis of concentrated oral solution of sodium and potassium magnesium sulfate (experimental group 1), concentrated oral solution of sodium and potassium magnesium sulfate + linalotide (experimental group 2), PEG(compound polyethylene glycol electrolyte powder) (control group) were analyzed and compared, in order to improve the intestinal preparation cleanliness rate of colonoscopy subjects.
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Study the overall design
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Research program design A single-center, single-blind, randomized controlled parallel design was adopted.
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Entry criteria Patients aged ≥18 years and ≤80 years who need intestinal preparation before colonoscopy.
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Study sample size In this study, PASS 15 software was used to estimate the sample size. According to previous research data, the intestinal cleanliness rates of the three groups of sodium and potassium magnesium sulfate oral concentrated solution group (test group 1), sodium and potassium magnesium sulfate oral concentrated solution + linalotide group (test group 2) and PEG group (control group) were set to be 86%, 90% and 69.36%, respectively, and the differences between the two groups and the control group were mainly compared. Considering that the total Class I error rate of multiple tests is controlled within 0.05, the bilateral test level of both tests is set as α=0.025, and the degree of assurance is 80%, and the minimum sample size of each group is calculated as 118 cases according to the equal ratio of 1:1:1. Considering a possible 20% shedding rate, it is planned to include 148 patients in each group, for a total of 444 patients.
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Criteria for judging clinical efficacy 4.1 Main therapeutic indexes Evaluation criteria for the main efficacy indicators: The proportion of subjects with a total Boston score ≥6 and a colon score ≥2 for each segment was recorded as effective.
the Boston bowel preparation scale (BBPS) can be used to evaluate the volume, morphology and mucosal clarity of stool and fluid in the bowel. The scoring criteria are as follows: 0 points: there is stool in the colon that cannot be cleared, and the mucosa can not be seen clearly, which is mostly seen in the stage without intestinal preparation;
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent;
- •Age 18-80 years old, gender is not limited;
- •The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
- •Non-lactating pregnant women and no pregnancy plan during the test;
- •Do not participate in any clinical trials for 3 months before and during the trial;
- •Participate voluntarily and sign informed consent.
排除标准
- •NYHA cardiac function grade III or IV;
- •Unstable angina pectoris in the convalescence period of acute myocardial infarction or in the near future;
- •have serious liver and kidney function diseases;
- •Suspected gastrointestinal obstruction or gastrointestinal perforation;
- •Pregnant or lactating women;
- •Mental illness or physical dysfunction can not cooperate with the examination;
- •People who are allergic to intestinal preparation drugs.
- •Patients who did not undergo colonoscopy after bowel clearing due to their own reasons;
- •Patients who can not tolerate general colonoscopy and terminate the examination;
- •Patients who requested withdrawal from the study.
研究组 & 干预措施
Magnesium sulfate sodium potassium solution group
Magnesium sulfate sodium potassium solution group: 3L magnesium sulfate sodium potassium oral concentrated solution. At 18:00 1d before the inspection, dissolve a package of contents into 200ml with water, and drink 250ml of water every half hour after that, drinking a total of 6 cups (that is, 1.5L); On the day of the examination (6 hours before the colonoscopy) repeat the same medication as the previous evening.
干预措施: OSS (Drug)
Magnesium sulfate sodium potassium solution group + linaclotide group
Magnesium sulfate sodium potassium solution + linaclotide group: 3L sodium magnesium sulfate potassium oral concentrated solution + linaclotide 290μg. One tablet of linalotide was taken orally at 18:00 one day before the examination, and then two packets of contents were dissolved into 300ml with water 6 hours before the colonoscopy. After that, 500ml of water was drunk every half hour, for a total of 6 cups.
干预措施: OSS+Linzess (Drug)
PEG (Compound polyethylene glycol electrolyte powder) group
PEG (Compound polyethylene glycol electrolyte powder) group: 3LPEG. At 18:00 1d before the inspection, dissolve a package of contents into 200ml with water, and drink 250ml of water every half hour after that, drinking a total of 6 cups; On the day of the examination (6 hours before the colonoscopy) repeat the same medication as the previous evening.
干预措施: PEG-Interferon Alfa (Drug)
结局指标
主要结局
BBPS
时间窗: 1day
The proportion of subjects with an overall Boston score ≥6 and a colon score ≥2 for each segment was considered valid.
次要结局
未报告次要终点
研究者
Shupei Li
student
Jinling Hospital, China