Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy

Completed

• Conditions: Colonoscopy; Bowel Preparation; Predictive Model

• Registration Number: NCT04101097
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy.

This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2019-09-21
• Study First Submitted QC: 2019-09-21
• Study First Posted: 2019-09-24
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-14
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Aged 18-80
• Using PEG for bowel preparation before colonoscopy

Exclusion Criteria

• Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
• Colon resection
• Suspected bowel obstruction
• Hemodynamically unstable
• Lactating or pregnant women
• Unwilling to provided informed content

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inadequate bowel preparation	1 hour	Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental\<2.

Secondary Outcome Measures

Name	Time	Method
Adequacy of proximal bowel preparation	1 hour	Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon\<2 or middle colon\<2
Adequacy of distal bowel preparation	1 hour	Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon\<2 or middle colon\<2

Trial Locations

Locations (5)

Department of Gastroenterology, Hongai Hospital; 🇨🇳 Xiamen, Fujian, China

Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University; 🇨🇳 Shenzhen, Guangdong, China

Department of Gastroenterology, Huaihe Hospital of Henan University; 🇨🇳 Kaifeng, Henan, China

Department of Gastroenterology, Shaanxi Second People's Hospital; 🇨🇳 Xi'an, Shaanxi, China

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China