Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Study Overview
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Brief Summary
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Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Detailed Description
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Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation. Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.

Conditions
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Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp

Intervention / Treatment
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* Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
* Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older, scheduled to undergo elective outpatient colonoscopy, and were able to provide informed consent. Exclusion Criteria: history of colorectal surgery severe colonic stricture or obstructing tumour dysphagia compromised swallowing reflex or mental status significant gastroparesis or gastric outlet obstruction known or suspected bowel obstruction or perforation severe chronic renal failure (creatinine clearance<30 ml/min severe congestive heart failure (New York Heart Association class III or IV) uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg) dehydration disturbance of electrolytes pregnancy or lactation haemodynamically unstable unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prucalopride group<br>2 mg Prucalopride plus 2 L Polyethylene Glycol regimen | Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen<br>* Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.<br>|
| Placebo Comparator: Placebo group<br>2 mg Placebo plus 2 L Polyethylene Glycol regimen | Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen<br>* Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of scores rating by Boston Bowel Preparation Scale between 2 groups. | This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between 2 groups. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate between 2 groups. |  | 9 months | 
| rate of adverse events between 2 groups. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prucalopride, Polyethylene Glycol, bowel preparation