Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification：a Multicenter, Endoscopist-blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,028
- Locations
- 1
- Primary Endpoint
- Boston Bowel Preparation Scale
Study Overview
Brief Summary
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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Investigator)
Masking Description
The allocation assignment of patients was performed by a designated technician at each center based on a computer-generated random sequence. The designated technician was not involved in the colonoscopy procedure.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
- •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.
Arms & Interventions
PEG (low-risk patients and high-risk patients)
The dosing regimen of low-risk patients and high-risk patients will only be PEG.
Intervention: PEG (Drug)
PEG+lactulose (low-risk patients and high-risk patients)
The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose.
Intervention: PEG+lactulose (Drug)
Outcomes
Primary Outcomes
Boston Bowel Preparation Scale
Time Frame: during colonoscopy
Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation.
Secondary Outcomes
- Cecal intubation time(during colonoscopy)
- Rate of adverse events(2 days)
- Adenoma Detection Rate(2 days)
- Cecal intubation rate(during colonoscopy)
- Withdrawal time(during colonoscopy)
- defecation frequency(2 days)
- Willingness to repeat bowel preparation(2 days)
Investigators
ChenMingkai
Chief physician of Department of Gastroenterology I
Renmin Hospital of Wuhan University