Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Shandong University600 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp

Interventions

2 mg Prucalopride plus 2 L Polyethylene Glycol regimenDRUG

Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.

2 mg Placebo plus 2 L Polyethylene Glycol regimenDRUG

Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 9 months

Secondary Outcomes

Polyp detection rate between 2 groups.

Time frame: 9 months

rate of adverse events between 2 groups.

Time frame: 9 months

Central Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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