Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: the control group The dosing regimen of high-risk patients will be PEG combined with lactulose. |
Drug: PEG+lactulose
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.
Other Names:
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| Experimental: CSP+lactulose group The dosing regimen of high-risk patients will be CSP combined with lactulose. |
Drug: CSP＋lactulose
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 .
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- Adenoma Detection Rate [2 days]
Diagnosis was confirmed by histologic examination
- Polyp Detection Rate [2 days]
Diagnosis was confirmed by histologic examination
- Rate of adverse events [2 days]
adverse events, such as vomiting, nausea, headache, abdominal distention, abdominal pain.
- Cecal intubation rate [during colonoscopy]
Colonoscopy reaches cecal region.
- Cecal intubation time [during colonoscopy]
Colonoscopy reaches cecal region.
- Withdrawal time [during colonoscopy]
The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.
- defecation frequency [2 days]
Frequency of bowel movement.
- patient satisfaction Assessment [2 days]
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;
Eligibility Criteria
Criteria
Inclusion Criteria:Adults undergoing colonoscopy who have at least one risk factor: 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.
Exclusion Criteria:
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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);
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Patients with galactosemia;
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hypersensitivity to any of the ingredients;
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Pregnancy or lactation;
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Use of lactulose,prokinetic agents or purgatives within 7 days;
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Unwilling to sign informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | 430060 |
Sponsors and Collaborators
- Renmin Hospital of Wuhan University
Investigators
- Study Director: Mingkai Chen, Ph.D & M.D, Renmin Hospital of Wuhan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WDRY2022-K082