A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Polyethylene Glycol
- Conditions
- Bowel Preparation
- Sponsor
- Shandong University
- Enrollment
- 429
- Locations
- 1
- Primary Endpoint
- Quality of Bowel Preparation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.
Investigators
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Polyethylene Glycol
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.
Intervention: Polyethylene Glycol
Outcomes
Primary Outcomes
Quality of Bowel Preparation
Time Frame: 10 months
The quality of bowel preparation is evaluated using BBPS.
Secondary Outcomes
- Adverse Events(10 months)
- Adenoma Detection Rate(10 months)
- Polyp Detection Rate(10 months)