Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
Conditions
Keywords
Prucalopride, Polyethylene Glycol, bowel preparation
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.
Interventions
DRUG2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.
DRUG2 mg Placebo plus 2 L Polyethylene Glycol regimen
Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.
Sponsors
Binzhou People's Hospital
Tai'an People's Hospital
Linyi People's Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| rate of adverse events between 2 groups. | 9 months |
| Polyp detection rate between 2 groups. | 9 months |
Countries
China
Contacts
Primary ContactLi Yanqing, MD, PhD
Outcome results
None listed