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临床试验/NCT04434625
NCT04434625已完成不适用

The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study

Air Force Military Medical University, China5 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
900
试验地点
5
主要终点
Adequate bowel preparation

研究概览

简要总结

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation.

The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

入选标准

  • Age: 18~75 years
  • Patients undergoing morning colonoscopy

排除标准

  • colon resection;
  • suspected bowel obstruction;
  • moderate or severe complications related to drinking the 1st or 2rd dose of PEG
  • hemodynamically unstable;
  • lactating or pregnant women;
  • no need to reach the ileocecal segment
  • unwilling to provided informed content.

研究组 & 干预措施

model-based interference group

Experimental

Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group colonoscopy directly.

干预措施: Polyethylene glycol (Drug)

结局指标

主要结局

Adequate bowel preparation

时间窗: 6 months

Defined by each segmental BBPS≥2

次要结局

  • Overall complication related to bowel preparation(6 months)
  • Adenoma detection rate(6 months)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (5)

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