Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Phase 4

• Conditions: Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
• Interventions: Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen; Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen

• Registration Number: NCT02781493
• Lead Sponsor: Shandong University

Brief Summary

Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Detailed Description

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.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-21
• Study First Submitted QC: 2016-05-21
• Study First Posted: 2016-05-24
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27
• Study Start: 2016-06
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prucalopride group	2 mg Prucalopride plus 2 L Polyethylene Glycol regimen	2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
Placebo group	2 mg Placebo plus 2 L Polyethylene Glycol regimen	2 mg Placebo plus 2 L Polyethylene Glycol regimen

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Polyp detection rate between 2 groups.	9 months
rate of adverse events between 2 groups.	9 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China