Development and Validation for Predicting Inadequate Bowel Preparation

• Sponsor: Ningbo No. 1 Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04290715
• Collaborator: (none)
• Enrollment: 1,644
• Location: 1
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 103.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polyethylene Glycol; Cathartics; Colonoscopy	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 1644 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Development and Validation for Predicting Inadequate Bowel Preparation Before Colonoscopy in Patients
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
group A	Other: no intervention; no intervention
group I	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. quality of bowel preparation [A colonoscopy procedure]

   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.

2. quality of bowel preparation [A colonoscopy procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ningbo First Hospital	Ningbo	Zhejiang	China	315010

Sponsors and Collaborators

• Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ningbo No. 1 Hospital
• ClinicalTrials.gov Identifier: NCT04290715
• Other Study ID Numbers: IBPN-V1.0
• First Posted: Mar 2, 2020
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 30, 2021