跳至主要内容
临床试验/NCT03315949
NCT03315949已完成3 期

Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose : A Single Center, Operator Blinded, Prospective Randomized Controlled Trial

Incheon St.Mary's Hospital1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
352
试验地点
1
主要终点
Boston Bowel Preparation Scale

研究概览

简要总结

Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy, same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing for morning colonoscopy was validated. To date, there was no study which compared the bowel cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The aim of current study is to compare the bowel cleansing efficacy, adverse events, and patient's tolerability between the two group.

Subjects who underwent colonoscopy for various reasons were included. After agreeing to participate in the study, study participants were randomly assigned to split dose or same day dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15 minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose group, bowel cleansing was started from 5AM for subjects who were scheduled to receive colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested 2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.

Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and laboratory tests were checked before colonoscopy. Study participants completed questionnaire which contained patient's satisfaction, tolerability, and adverse event during bowel cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared between the two groups. Successful bowel cleansing was estimated 85% for split dose group.

The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be recruited.

详细描述

Randomization and blinding:

Randomization will be done using computer generated randomization list. A specialized nurse will explain the method of bowel cleansing. Investigators (endoscopists) are blinded to bowel cleansing method.

Endpoint:

Primary end point is successful bowel cleansing rated by Boston bowel preparation (BBPS) scale. Successful bowel cleansing is defined as all segment is 2 or 3 points. Endoscopists will assess BBPS when colonoscopy withdrawal.

Secondary end point was patient's tolerability and safety profile including adverse events. Patient's satisfaction to the different bowel cleansing method and adverse events (nausea, vomiting, dizziness, fatigue) will be investigated by questionnaire before colonoscopy. Blood test will be done before colonoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all subjects who undergo colonoscopy for various reasons.

排除标准

  • hemodynamic instability
  • ileus or bowel obstruction
  • active inflammatory bowel disease
  • advanced colon cancer

研究组 & 干预措施

Same-day dose group

Experimental

Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.

干预措施: Polyethylene Glycol (PEG) (Drug)

Split-dose group

Active Comparator

Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.

干预措施: Polyethylene Glycol (PEG) (Drug)

结局指标

主要结局

Boston Bowel Preparation Scale

时间窗: Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal

Primary endpoint=Successful bowel cleansing (all segmental score 2 or above) \* Boston bowel preparation scale (0-9) Sum of 3 segment of bowel. 0=inadequate 1. poor 2. good 3. excellent

次要结局

未报告次要终点

研究者

发起方
Incheon St.Mary's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae-Geun Gweon

Clinical associate professor

Incheon St.Mary's Hospital

研究点 (1)

Loading locations...

相似试验