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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
150
On the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM. On the day of the procedure, patients took 50 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.
On the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 150 mL of CSP at 8:00 PM ,followed by 2000ml of clarified liquid. On the day of the procedure, 4-6 hours before colonoscopy, patients took 50 mL lactulose solution and the remaining 150mL of CSP ,then followed by 750ml of clarified liquid .
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGBoston 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
Polyp 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.
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Time frame: 2 days
patient satisfaction Assessment
Patients' satisfaction score for bowel preparation (3 points: completely tolerable and very satisfied; 2 points: nausea and other discomfort, but still tolerable and satisfactory; 1: unable to tolerate, not satisfied); And whether the patient is willing to use the bowel cleansing program for colonoscopy;
Time frame: 2 days