Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy

Colonoscopy Clinical Trial

Official title:

Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160104
• Other study ID #: KT20190827-2
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2019
• Source: Fourth Military Medical University
• Contact: Hui Jia, MD
• Phone: +86-2984771536
• Email: jiahuifmmu[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. Thus, it is important to set up a model to predict the quality of bowel preparation individually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-90 years old who undergoing colonoscopy

Exclusion Criteria:

• failed colonoscopy because of technical chanllenge or poor tolerance of patients

• history of colorectal surgery

• prior finding of severe colonic stricture or obstructing tumor

• dysphagia

• compromised swallowing reflex or mental status

• significant gastroparesis or gastric outlet obstruction or ileum

• known or suspected bowel obstruction or perforation

• pregnancy

• unable to give informed consent

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Other:
• Questionnaire
Patients were asked to complete a questionnaire before colonoscopy. Bowel preparation was subsequently assessed by single endoscopist in each center using Boston bowel preparation quality score (BBPS). Both univariate and multivariate logistic regression models were used to identify high-risk factors associated with IBP and a predicting model with the bowel preparation score (BPS) was developed in the training cohort.
• Questionnair
Patients were asked to complete a questionnaire before colonoscopy. The predicting modle established by the training cohort will be used to assessing the preparation of validation cohort. The result will compared with endoscopists assessment of preparation.

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston bowel preparation quality scale	A 10-point scale (0 is worst, 9 is best)	1 hour