Development and Validation for Predicting Inadequate Bowel Preparation

NCT04290715 | Completed DMC

• 1 other identifier: IBPN-V1.0
• Study Type: observational
• Target: 1,644
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyethylene Glycol; Cathartics; Colonoscopy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

group A

Other: no intervention

group I

Other: no intervention

Interventions

no intervention OTHER

no intervention

group A; group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 2, 2020
• Study Start: January 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

CN (1)