Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation

Wuhan University

Status: Enrolling

Conditions: Bowel Preparation Before Colonoscopy

Treatments: Drug: CSP＋lactulose; Drug: PEG+lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT05498714

WDRY2022-K082

Details and patient eligibility

About

The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population.

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.This is a single-center ,endoscopist-blinded study to compare the efficacy of CSP combined with lactulose and PEG combined with lactulose 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: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Adults undergoing colonoscopy who have at least one risk factor: 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.

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

---

150 participants in 2 patient groups

the control group

Active Comparator group

Description:

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

Treatment:

Drug: PEG+lactulose

CSP+lactulose group

Experimental group

Description:

The dosing regimen of high-risk patients will be CSP combined with lactulose.

Treatment:

Drug: CSP＋lactulose