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Clinical Trials/NCT04434625
NCT04434625
Completed
Not Applicable

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 sites in 1 country900 target enrollmentJune 14, 2020

Overview

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

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 14, 2020
End Date
March 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Yanglin Pan

Associated professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

model-based interference group

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.

Intervention: Polyethylene glycol

Outcomes

Primary Outcomes

Adequate bowel preparation

Time Frame: 6 months

Defined by each segmental BBPS≥2

Secondary Outcomes

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

Study Sites (5)

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