Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

Wuhan University

Status: Completed

Conditions: Bowel Preparation Before Colonoscopy

Treatments: Drug: PEG+lactulose; Drug: PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT04582942

2019-X2-73

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.

Full description

The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.

Enrollment: 2,028 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults undergoing colonoscopy.

Exclusion criteria

• 1.presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
• 2.Patients with galactosemia;
• 3. hypersensitivity to any of the ingredients;
• 4.Pregnancy or lactation;
• 5.Use of lactulose,prokinetic agents or purgatives within 7 days;
• 6.Unwilling to sign informed consent.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,028 participants in 2 patient groups, including a placebo group

PEG (low-risk patients and high-risk patients)

Placebo Comparator group

Description:

The dosing regimen of low-risk patients and high-risk patients will only be PEG.

Treatment:

Drug: PEG

PEG+lactulose (low-risk patients and high-risk patients)

Experimental group

Description:

The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose.

Treatment:

Drug: PEG+lactulose