External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy

Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Department of Gastroenterology, Hongai Hospital
    • Xiamen, Fujian, China
      • Xiang'an Hospital of Xiamen University
  • Hainan
    • Qionghai, Hainan, China
      • Department of Gastroenterology, Qionghai people's hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Department of Gastroenterology, Bethune international peace hospital
  • Henan
    • Zhengzhou, Henan, China
      • Department of Gastroenterology，Zhengzhou Central Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710005
      • Department of gastroenterology, Shaanxi Second People's Hospital
    • Xi'an, Shaanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases
    • Xi'an, Shaanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shannxi
    • Xi'an, Shannxi, China
      • The First Affiliated Hospital of Xi'an Medical University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Department of Gastroenterology，Shanxi Bethune hospital
  • Sichuang
    • Chengdu, Sichuang, China
      • Department of Gastroenterology，Chengdu third people's hospital
  • Xinjiang
    • Shihezi, Xinjiang, China, 832008
      • Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective study involving eleven tertiary-centers in China.

Description

Inclusion Criteria:

• Age≥18
• Patient undergoing colonoscopy

Exclusion Criteria:

• Patients with prior colectomy
• Unable to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate bowel preparation	Defined by each segmental BBPS≥2	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of yellow, clear stool in the last defecation	The characteristics of the last stool was self-evaluated by patients based on a picture containing different kind of stool examples.	1 hour

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: KT20200324-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No