Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification：a Multicenter, Endoscopist-blinded Randomized Controlled Trial

Conditions
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Bowel Preparation Before Colonoscopy

Intervention / Treatment
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* Drug: PEG
* Drug: PEG+lactulose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients scheduled for colonoscopy were stratified into low- and high-risk patients based on the inclusion criteria. Low- and high-risk patients were randomized to the PEG alone or lactulose combined with PEG group respectively.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PEG (low-risk patients and high-risk patients)<br>The dosing regimen of low-risk patients and high-risk patients will only be PEG. | Drug: PEG<br>* Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.<br>* Other names: only used PEG;|
| Experimental: PEG+lactulose (low-risk patients and high-risk patients)<br>The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose. | Drug: PEG+lactulose<br>* On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.<br>* Other names: PEG combined with lactulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale | 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. | during colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate | Diagnosis was confirmed by histologic examination | 2 days | 
| Rate of adverse events | adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain. | 2 days | 
| Cecal intubation rate | Colonoscopy reaches cecal region. | during colonoscopy | 
| Cecal intubation time | Colonoscopy reaches cecal region. | during colonoscopy | 
| Withdrawal time | The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps. | during colonoscopy | 
| defecation frequency | Frequency of bowel movement. | 2 days | 
| Willingness to repeat bowel preparation | The number of patients have a willingness to undergo a repeated bowel preparation if needed. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Lactulose, Polyethylene glycol, Bowel preparation