Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clínicas Dr. Manuel Quintela

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Bisacodyl 5 MG

    Drug

    On 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

    Drug

    On 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

124 Participants
are divided into 2 treatment groups
Group A: BisacodylExperimental treatment 1 intervention
Group B: PrucalopridaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Periprocedural

Secondary outcomes

1

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.

Time frame
Periprocedural
2

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.

Time frame
Until the completion of the studies. Average 1 year
3

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.

Time frame
Until the completion of the studies. Average 1 year.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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