Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation

Study Overview
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Brief Summary
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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.

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.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.

Official Title
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Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation#a Single-center,Endoscopist-blinded Randomized Controlled Trial

Conditions
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Bowel Preparation Before Colonoscopy

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


Participation Criteria
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Eligibility Criteria
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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: 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); Patients with galactosemia; hypersensitivity to any of the ingredients; Pregnancy or lactation; Use of lactulose,prokinetic agents or purgatives within 7 days; 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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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the control group<br>The dosing regimen of high-risk patients will be PEG combined with lactulose. | Drug: PEG+lactulose<br>* 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.<br>* Other names: PEG combined with lactulose;|
| Experimental: CSP+lactulose group<br>The dosing regimen of high-risk patients will be CSP combined with lactulose. | Drug: CSP＋lactulose<br>* 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 .<br>* Other names: CSP 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 | 
| Polyp 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 | 
| 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; | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Bowel Preparation, Polyethylene glycol, Compound Sodium Picosulfate, Lactulose