A Predictive Model for Inadequate Bowel Preparation

NCT ID: NCT03704571

Last Updated: 2019-11-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-08-30

Brief Summary

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We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.

Detailed Description

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Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Tailored Group

In the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy.

Group Type EXPERIMENTAL

Polyethylene Glycol

Intervention Type DRUG

In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.

In the control group, all the patients are given routine regimens.

Control Group

In the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min.

Group Type ACTIVE_COMPARATOR

Polyethylene Glycol

Intervention Type DRUG

In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.

In the control group, all the patients are given routine regimens.

Interventions

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Polyethylene Glycol

In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.

In the control group, all the patients are given routine regimens.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-75 years undergoing colonoscopy

Exclusion Criteria

* known or suspected bowel obstruction, stricture or perforation
* compromised swallowing reflex or mental status
* severe chronic renal failure(creatinine clearance \< 30 ml/min)
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* dehydration
* disturbance of electrolytes
* pregnancy or lactation
* hemodynamically unstable
* unable to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

director of Qilu Hospital gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuli Zuo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2018SDU-QILU-G111

Identifier Type: -

Identifier Source: org_study_id

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