Development and Validation for Predicting Inadequate Bowel Preparation

Development and Validation for Predicting Inadequate Bowel Preparation Before Colonoscopy in Patients

High-quality colonoscopy is considered the gold standard for the detection and prevention of colorectal cancer, and its efficacy is predicated on optimal colon cleansing.However, about 18%-35% of patients were still reported to suffer inadequate bowel preparation. Although several predictive models exist, the current guideline indicates that there is insufficient evidence to recommend the use of a predictive model for clinical practice.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Polyethylene Glycol; Cathartics
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 1644

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

1. patients undergoing colonoscopy.
2. patients older than 18 years

Description

Inclusion Criteria:

• patients undergoing colonoscopy.
• patients older than 18 years.

Exclusion Criteria:

• Emergency colonoscopy.
• Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
• Pregnant or breastfeeding.
• No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives < 90% of prescribed dose).
• Refuse to sign informed consent.
• The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
• Temporarily change to colonoscopy for other reasons.
• Incomplete colonoscopy due to insufficient parenteral preparation.
• Lack of complete data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A	Other: no intervention; no intervention
group I	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of bowel preparation	The OBPS is a validated scoring system with scores between 0 and 14, where 0 is the best score. The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon. In addition, a score 0-2 is added to indicate the total amount of luminal fluid. For all participants, OBPS score will be used when the colonscopy is inserting.	A colonoscopy procedure
quality of bowel preparation	The BBPS is another validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon. For all participants, BBPS score will be used when colonscopy is withdrawing.	A colonoscopy procedure

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IBPN-V1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No