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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.

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
GroupInterventionDescription
Prucalopride group2 mg Prucalopride plus 2 L Polyethylene Glycol regimen2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
Placebo group2 mg Placebo plus 2 L Polyethylene Glycol regimen2 mg Placebo plus 2 L Polyethylene Glycol regimen
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China
Yanqing Li, MD, PhD
Contact
86-0531-82169236
liyanqing@sdu.edu.cn

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