Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Boston Bowel Preparation Scale
研究概览
简要总结
To compare intestinal preparation with Lactulose vs. Sodium Phosphate as the better agent for performing high-quality colonoscopies at the Civil Hospital Fray Antonio Alcalde and the Civil Hospital Juan I. Menchaca, both in Guadalajara, Mexico; as well as Hospital Santo Tomás in Panama City, Panama; and Hospital Gustavo Nelson Collado Ríos in Chitré, Panama; during the period from April 1, 2025, to November 30, 2025. The comparison will focus on colonoscopy quality, patient tolerance, satisfaction, and electrolyte changes, using the agents orally as part of the bowel preparation prior to the colonoscopy procedure.
详细描述
Randomized Double-Blind Clinical Trial conducted from April 1, 2025, to November 30, 2025, involving patients scheduled for outpatient colonoscopy at the Coloproctology Departments of the Civil Hospital Fray Antonio Alcalde, Civil Hospital Juan I. Menchaca (both in Guadalajara, Mexico), Hospital Santo Tomás in Panama City, Panama, and Hospital Gustavo Nelson Collado Ríos in Chitré, Panama.
Patients undergoing elective or emergency therapeutic colonoscopies, as well as those with certain medical conditions or pregnancy, were excluded from the study. Factors related to bowel preparation were considered, with particular emphasis on the characteristics of the chosen preparation agent, its effects, and findings observed during each patient's colonoscopy. All data were collected in a database, which will be shared via a digital platform using the SPSS statistical package for data analysis, followed by the development of conclusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
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
- •Indication for Scheduled Colonoscopy: Participants must have a valid clinical indication for undergoing a scheduled colonoscopy, such as part of a colorectal cancer screening program, evaluation of gastrointestinal symptoms, or follow-up of previously diagnosed colorectal conditions.
- •Ability to Provide Informed Consent: Participants must have the physical and mental capacity to understand the nature of the study and voluntarily provide informed consent to participate.
排除标准
- •History of Intestinal Obstruction: Participants with a known or suspected history of intestinal obstruction will be excluded due to the potential risks associated with the administration of bowel preparation agents.
- •Known Intolerance to Lactulose or Sodium Phosphate: Participants with a known intolerance to lactulose or sodium phosphate will be excluded due to the risk of severe adverse reactions.
- •Pregnancy and Lactation: Pregnant or breastfeeding women will be excluded due to the lack of safety data on bowel preparation agents in this population.
- •Interfering Clinical Conditions (Comorbidities): Participants with medical conditions that could interfere with study participation or affect the interpretation of results will be excluded, such as decompensated heart failure, chronic renal or liver disease, and a history of colonic resection.
结局指标
主要结局
Boston Bowel Preparation Scale
时间窗: 1 day
A total score of 6 or more, with no segment below 2.
次要结局
- Hydroelectrolytic changes.(Two blood drawns: During screening period and baseline visit.)
- Adverse gastrointestinal effects due to bowel preparation.(Baseline.)
- Palatability(Baseline)
- Adenoma detection rate(Baseline)
研究者
Roberto Ulises Cruz Neri
Coloproctologist
Hospital Civil de Guadalajara