Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
- Conditions
- Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
- Interventions
- Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimenDrug: 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
- Patients 18 years of age or older,
- scheduled to undergo elective outpatient colonoscopy,
- and were able to provide informed consent.
- 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
Related Research Topics
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Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China
Department of Gastroenterology, Qilu Hospital, Shandong University🇨🇳Jinan, Shandong, ChinaYanqing Li, MD, PhDContact86-0531-82169236liyanqing@sdu.edu.cn