Tailored Bowel Preparation According to Bristol Stool Form Scale: a Prospective, Randomized, Controlled, Investigator-blinded, Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.
研究概览
简要总结
The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
详细描述
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.
The Bristol stool form scale ( BSFS) was developed in 1988 by O'Donnell LJD et al and was widely applied in both gastrointestinal study and clinical practice. BSFS divides human stool into 7 different styles according to its moisture content. In our clinical work, we find that it is prone to gain poor bowel cleansing quality in patients who pass type 1or 2 stool. Unfortunately, there is lacking of study on tailored bowel preparation according to Bristol stool form scale. Thus, we intend to develop an easy, practical, BSFS based tailored bowel cleansing regimen, in order to serve clinical work and research.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older,
- •scheduled to undergo elective outpatient colonoscopy,
- •and were able to provide informed consent.
排除标准
- •history of colorectal surgery
- •severe colonic stricture or obstructing tumour
- •dysphagia
- •compromised swallowing reflex or mental status
- •significant gastroparesis or gastric outlet obstruction
- •known or suspected bowel obstruction or perforation
- •severe chronic renal failure (creatinine clearance<30 ml/min
- •severe congestive heart failure (New York Heart Association class III or IV)
- •uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •inflammatory bowel disease or megacolon
- •dehydration
- •disturbance of electrolytes
- •pregnancy or lactation
- •haemodynamically unstable
- •unable to give informed consent.
研究组 & 干预措施
group1
Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.
干预措施: Standard Bowel Prep (2L PEG-ELP) (Drug)
group2
Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure. ( 2L PEG-ELP and 10mg bisacodyl )
干预措施: 2L PEG-ELP and 10mg bisacodyl (Drug)
group3
Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.
干预措施: Standard Bowel Prep (2L PEG-ELP) (Drug)
结局指标
主要结局
Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.
时间窗: 9 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
次要结局
- Caecal intubation rate among 3 groups.(9 months)
- Polyp detection rate among 3 groups.(9 months)
- Rate of non-compliance with instructions among 3 groups.(9 months)
- Willingness to repeat bowel preparation among 3 groups.(9 months)
- Withdrawal time among 3 groups.(9 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University