Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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;
1. 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.

Arm && Interventions

Group	Intervention	Description
PEG+lactulose (low-risk patients and high-risk patients)	PEG+lactulose	The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose.
PEG (low-risk patients and high-risk patients)	PEG	The dosing regimen of low-risk patients and high-risk patients will only be PEG.

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale	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 Outcome Measures

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

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