Development and Validation for Predicting Inadequate Bowel Preparation

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290715
• Other study ID #: IBPN-V1.0
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2021
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1644
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cathartics
• Colonoscopy
• Polyethylene Glycol

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Ningbo First Hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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