Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy

NCT ID: NCT04160104

Last Updated: 2019-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation Colonoscopy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Training cohort

This cohort was used to establish the bowel preparation score (BPS).

Questionnaire

Intervention Type OTHER

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.

Validation cohort

This cohort was used to verify the bowel preparation score (BPS).

Questionnair

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hui Jia, MD

Role: CONTACT

+86-2984771536

Facility Contacts

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Hui Jia, MD

Role: primary

+862984771536

Other Identifiers

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KT20190827-2

Identifier Type: -

Identifier Source: org_study_id

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