Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy

NCT04160104 | Unknown DMC

• 1 other identifier: KT20190827-2
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bowel Preparation; Colonoscopy

Keywords

Bowel preparation; BBPS

Outcome Measures

Primary Outcomes (1)

• Boston bowel preparation quality scale

  A 10-point scale (0 is worst, 9 is best)

  1 hour

Study Arms (2)

Training cohort

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

Other: Questionnaire

Validation cohort

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

Other: Questionnair

Interventions

Questionnaire 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.

Training cohort

Questionnair 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.

Validation cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective study involving two tertiary-centers in China.

You may qualify if:

• Patients aged 18-90 years old who undergoing colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, 710032, China

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Hui Jia, MD

CONTACT

+86-2984771536; jiahuifmmu@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: April 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

CN (1)