High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- the quality of bowel preparation
研究概览
简要总结
Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However, a significant number of patients, especially those constipated patients, failed colonoscopies due to poor bowel cleaning. Inadequate preparation may also lead to missed colonic lesions. The study is based on the hypothesis: itopride hydrochloride, a prokinetic agent, its dual role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition make it an appropriate adjuvant for bowel preparation. It was reported to promote colonic peristalsis, shorten colonic transit time and accelerate propulsion of colonic luminal contents through inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo. So this study is to determine the efficacy, tolerance and safety of high dose of itopride, when given in different times before administration of PEG-E, for colonic preparation in patients with chronic constipation.
详细描述
Colonoscopy is a reliable procedure for the investigation of colonic and distal terminal ileum disease. The diagnostic accuracy of colonoscopy is dependent on visualization of the colonic mucosa; hence an appropriate bowel preparation is essential for the examination. Despite multiple lavage were used throughout the years, the suboptimal cleaning level have been reported vary from 10% to more than 20% and up to one-third of incomplete or failed colonoscopies can be ascribed to poor bowel preparation. So it is important for us to search a new regimen for bowel 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 (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
- 否
入选标准
- •Patients suspected colonic disease and suffered from chronic constipation were referred for colonoscopy and enrolled in the study. Chronic constipation was diagnosed on the basis of Rome III criteria.Suspected colonic disease was defined as:
- •recent change of bowel habits;
- •obscure GI bleeding (hemafecia, melena or positive fecal occult blood test);
- •obscure abdominal pain;
- •weight loss;
- •positive findings in the colon on GI imaging;
- •serological test referred to colorectal cancer such as CEA elevated obviously;
- •family history of colorectal cancer or adenomatous polyps.
排除标准
- •usage of prokinetic agents such as itopride, mosapride within 4 weeks and tricyclic antidepressants 8 weeks prior to entering the protocol;
- •known allergies or other contraindication to PEG or itopride;
- •a history of abdominal surgery or bowel obstruction;
- •pregnant or lactating;
- •conditions associated with severe cardiac, hepatic, or renal impairment.
研究组 & 干预措施
group PEG
This group is set as a control group and received 2 packets of Polyethylene glycol electrolyte solutions on the morning of the examination day as us we usually done.
干预措施: Polyethylene glycol electrolyte solutions (Drug)
group PEG+Itp
Patients in group were assigned to itopride half hour before administration of lavage solution in the morning of examination day.
干预措施: itopride and polyethylene glycol electrolyte solutions (Drug)
group PEG+4Itp
Patients in this group received itopride three times 24 hours before the examination day and another time 30 min before administration of lavage solution.
干预措施: itopride and polyethylene glycol electrolyte solutions (Drug)
结局指标
主要结局
the quality of bowel preparation
时间窗: the day of colonoscopy examination
the Boston Bowel Preparation Scale (BBPS): the colon was divided into 3 broad segments: the right side (the cecum and ascending colon), the middle section (the hepatic flexures, transverse colon and splenic flexures), and the left side of the colon (the descending colon, sigmoid colon, and rectum). Each region of the colon receives a score from 0 to 3 as summarized in table 1, score 0 was considered poor preparation while score 3 indicated good cleaning quality. And these segment scores are summed for a total BBPS score ranged from 0 to 9.
次要结局
- time of examination(the day of examination)
- intestinal bubble scale(the day of colonoscopy examination)
- times of defecation(the day before and the day of examination)
研究者
Xiaobo Li
Xiaobo Li
Shanghai Jiao Tong University School of Medicine