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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
2,028
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.
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.
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
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.
Time frame: during colonoscopy
Adenoma Detection Rate
Diagnosis was confirmed by histologic examination
Time frame: 2 days
Rate of adverse events
adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain.
Time frame: 2 days
Cecal intubation rate
Colonoscopy reaches cecal region.
Time frame: during colonoscopy
Cecal intubation time
Colonoscopy reaches cecal region.
Time frame: during colonoscopy
Withdrawal time
The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.
Time frame: during colonoscopy
defecation frequency
Frequency of bowel movement.
Time frame: 2 days
Willingness to repeat bowel preparation
The number of patients have a willingness to undergo a repeated bowel preparation if needed.
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Time frame: 2 days