About this trial
The objective of this randomized clinical trial is to compare prucalopride versus bisacodyl as a stimulant agent for bowel cleansing preparation prior to colonoscopy in patients undergoing the procedure at the Endoscopy Unit of the Hospital de Clínicas. The main research questions this study aims to answer are:
Is prucalopride superior or equivalent to bisacodyl as a stimulant agent for bowel cleansing preparation before colonoscopy? Is the tolerability of prucalopride better, equivalent, or worse compared to bisacodyl? The investigators will compare the standard bowel cleansing preparation using polyethylene glycol (PEG) in combination with either bisacodyl or prucalopride as the stimulant agent.
Participants will be randomized into two groups, both receiving the same base preparation with different stimulant agents.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All patients over 18 years of age.
Without prior colonic surgical interventions.
Who attend the Digestive Endoscopy service to undergo a colonoscopy.
Disqualifiers
Patients who voluntarily choose not to participate in the study.
Pregnant women.
Patients with rectocolonic resections and/or ileostomies.
Inflammatory bowel disease.
Trial design
Parallel
Treatments tested in this trial
Bisacodyl 5 MG
DrugOn the day prior to the procedure, the group receiving bisacodyl will take 4 tablets (5 mg each) at 4:00 PM. Subsequently, at 6:00 PM, they will dissolve 3 sachets of PEG in 3 liters of water (1 sachet per liter) and ingest half of the preparation, that is, 1.5 liters over a period of 2 hours. At 10:00 PM, they will ingest the remaining 1.5 liters over another 2-hour period.
Prucalopride 2mg
DrugOn the day prior to the procedure, the group receiving prucaloprida will take 1 tablet (2 mg) at 4:00 PM. Subsequently, at 6:00 PM, they will dissolve 3 sachets of PEG in 3 liters of water (1 sachet per liter) and ingest half of the preparation, that is, 1.5 liters over a period of 2 hours. At 10:00 PM, they will ingest the remaining 1.5 liters over another 2-hour period.
Treatment groups
Trial outcomes
Primary outcomes
Boston scale
Scale used to evaluate the quality of bowel preparation during video colonoscopy. Score 0-9; adequate preparation (Boston ≥ 2 points in each colonic segment), inadequate preparation (Boston \< 2 points in any of the segments).
Secondary outcomes
Tolerability of bowel preparation. Presence or absence of the following symptoms during bowel preparation: nausea, vomiting, abdominal pain or distension, headache, dizziness, fatigue, palpitations, and rectal bleeding.
Refers to the presence or absence of the following symptoms during bowel preparation: nausea, vomiting, abdominal pain or distension, headache, dizziness, fatigue, palpitations, and rectal bleeding. Tolerability will be assessed through a standardized questionnaire administered prior to colonoscopy.
Overall adenoma detection rate
Conceptual definition: A key quality indicator in colonoscopy. An overall adenoma detection rate ≥25% of procedures is considered acceptable (≥30% in men and ≥20% in women). Operational definition: Calculated as the number of adenomas/adenocarcinomas (confirmed by histological diagnosis) divided by the total number of colonoscopies performed, multiplied by 100.
Overall cecal intubation rate
Conceptual definition: A quality indicator in colonoscopy. An acceptable rate is ≥95% for screening colonoscopies and ≥90% for other types of colonoscopies. Operational definition: Calculated as the number of colonoscopies in which the ileocecal valve is visualized, divided by the total number of colonoscopies performed, multiplied by 100.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: