Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 主要终点
- Boston scale
研究概览
简要总结
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.
详细描述
An analytical, experimental, prospective study will be conducted, specifically a triple-blind randomized clinical trial (blinding of the endoscopist, investigators, and statistician), comparing a bowel preparation regimen for colonoscopy using prucalopride versus bisacodyl.
Patients referred to the Digestive Endoscopy Unit of the Gastroenterology Department at the Hospital de Clínicas for colonoscopy (VCC) who meet the inclusion criteria will be invited to participate in the study. Referrals will include both hospitalized patients and outpatients from various clinic services.
Statistical Analysis Frequency tables and charts will be used to describe qualitative variables. Measures of central tendency and dispersion (mean ± standard deviation or median and interquartile range [IQR]) will be used for continuous variables depending on the distribution assessed by the Kolmogorov-Smirnov test.
Associations between qualitative variables will be analyzed using the Chi-square test or Fisher's exact test when expected frequencies are less than 5. If a statistically significant association is found, the strength of the association will be expressed using the Relative Risk (RR) and its corresponding 95% Confidence Interval (CI).
Differences between groups in normally distributed continuous variables will be analyzed using the Student's t-test for independent samples, and for non-normally distributed variables, the Mann-Whitney U test will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients over 18 years of age.
- •Without prior colonic surgical interventions.
- •Who attend the Digestive Endoscopy service to undergo a colonoscopy.
排除标准
- •Patients who voluntarily choose not to participate in the study.
- •Pregnant women.
- •Patients with rectocolonic resections and/or ileostomies.
- •Inflammatory bowel disease.
- •Inadequate bowel preparation in a previous colonoscopy.
- •Suspected intestinal obstruction or perforation.
- •Intestinal intussusception.
- •Oral iron intake within the last 10 days.
- •Emergency colonoscopies.
- •Hypersensitivity to any component of the bowel preparation solutions.
- •Chronic kidney disease on dialysis.
- •Uncorrected severe electrolyte imbalances.
- •Major psychiatric disorders.
- •Low intellectual quotient.
- •Severe constipation (≤ 1 bowel movement per week).
- •Chronic diarrhea with high frequency (≥ 4 daily bowel movements of uniformly decreased consistency for more than 4 weeks).
- •Decompensated cardiac diseases (ischemic heart disease, congestive heart failure, unstable angina, arrhythmias, and uncontrolled hypertension).
研究组 & 干预措施
Bisacodyl
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.
干预措施: Bisacodyl 5 MG (Drug)
Prucaloprida
On the day prior to the procedure, the group receiving prucalopride will take one 2 mg tablet 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.
干预措施: Prucalopride 2mg (Drug)
结局指标
主要结局
Boston scale
时间窗: Periprocedural
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).
次要结局
- 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.(Periprocedural)
- Overall adenoma detection rate(Until the completion of the studies. Average 1 year)
- Overall cecal intubation rate(Until the completion of the studies. Average 1 year.)
研究者
Ignacio Moratorio
Principal investigator
Hospital de Clínicas Dr. Manuel Quintela