A Predictive Model for Inadequate Bowel Preparation

Shandong University

Status: Completed

Conditions: Bowel Preparation

Treatments: Drug: Polyethylene Glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT03704571

2018SDU-QILU-G111

Details and patient eligibility

About

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

Enrollment: 429 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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429 participants in 2 patient groups

Tailored Group

Experimental group

Description:

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.

Treatment:

Drug: Polyethylene Glycol

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Polyethylene Glycol