A Predictive Model for Inadequate Bowel Preparation

A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Bowel Preparation
• Intervention / Treatment: Drug: Polyethylene Glycol

• Study Type: Interventional
• Enrollment (Actual): 429
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Bowel Preparation	The quality of bowel preparation is evaluated using BBPS.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate	The proportion of patients from whom at least one adenoma can be detected.	10 months
Polyp Detection Rate	The proportion of patients from whom at least one polyp can be detected.	10 months
Adverse Events	Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on.	10 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, MD, PhD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: randomized controlled trial; colonoscopy; adenoma; bowel preparation; predictive model
• Other Study ID Numbers: 2018SDU-QILU-G111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No