Clinical trial NCT05498714: Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation
Official title: Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation#a Single-center,Endoscopist-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation Before Colonoscopy
Keywords: Colonoscopy
Bowel Preparation
Polyethylene glycol
Compound Sodium Picosulfate
Lactulose
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Boston Bowel Preparation Scale
timeFrame: during colonoscopy
Secondary outcomes:
measure: Adenoma Detection Rate
timeFrame: 2 days
measure: Polyp Detection Rate
timeFrame: 2 days
measure: Rate of adverse events
timeFrame: 2 days
measure: Cecal intubation rate
timeFrame: during colonoscopy
measure: Cecal intubation time
timeFrame: during colonoscopy
measure: Withdrawal time
timeFrame: during colonoscopy
measure: defecation frequency
timeFrame: 2 days
measure: patient satisfaction Assessment
timeFrame: 2 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, Ph.D & M.D
role: STUDY_DIRECTOR
References: