A Predictive Model for Inadequate Bowel Preparation

Not Applicable

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: Polyethylene Glycol

• Registration Number: NCT03704571
• Lead Sponsor: Shandong University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-11-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-08-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Group	Polyethylene Glycol	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.
Control Group	Polyethylene Glycol	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.

Primary Outcome Measures

Name	Time	Method
Quality of Bowel Preparation	10 months	The quality of bowel preparation is evaluated using BBPS.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China