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Clinical Trials/NCT04101097
NCT04101097
Completed
Not Applicable

Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy

Air Force Military Medical University, China5 sites in 1 country900 target enrollmentSeptember 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonoscopy
Sponsor
Air Force Military Medical University, China
Enrollment
900
Locations
5
Primary Endpoint
Inadequate bowel preparation
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 3, 2019
End Date
March 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Air Force Military Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Yanglin Pan

Associate Professor

Air Force Military Medical University, China

Eligibility Criteria

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

Outcomes

Primary Outcomes

Inadequate bowel preparation

Time Frame: 1 hour

Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental\<2.

Secondary Outcomes

  • Adequacy of proximal bowel preparation(1 hour)
  • Adequacy of distal bowel preparation(1 hour)

Study Sites (5)

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