Идёт набор NCT07060222

Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.

Фаза IV С лечением Bowel Preparation for Colonoscopy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Bowel preparation before colonoscopy: Lactulose., Bowel preparation before colonoscopy: Sodium phosphate..
Кому может быть актуально: Состояния в реестре: Bowel Preparation for Colonoscopy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Мексика, Panama
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

Комбинированный продукт Bowel preparation before colonoscopy: Lactulose.
In this randomized, multicenter, single-blind clinical trial, each patient who meets our inclusion criteria will be assigned a randomized code to be included in one of the two study arms, that is, one of the groups and the assigned bowel preparation for the colonoscopy. The benefits and minimal risks of participation will be explained to them, and they will also be asked to sign an informed consent form so that we can proceed with the colonoscopy and collect all the necessary data for our protoc
Комбинированный продукт Bowel preparation before colonoscopy: Sodium phosphate.
In this randomized, multicenter, single-blind clinical trial, each patient who meets our inclusion criteria will be assigned a randomized code to be included in one of the two study arms, that is, one of the groups and the assigned bowel preparation for the colonoscopy. The benefits and minimal risks of participation will be explained to them, and they will also be asked to sign an informed consent form so that we can proceed with the colonoscopy and collect all the necessary data for our protoc

Первичные конечные точки

Boston Bowel Preparation Scale [Срок оценки: 1 day]

Вторичные конечные точки (4)

Hydroelectrolytic changes. [Срок оценки: Two blood drawns: During screening period and baseline visit.]
Adverse gastrointestinal effects due to bowel preparation. [Срок оценки: Baseline.]
Palatability [Срок оценки: Baseline]
Adenoma detection rate [Срок оценки: Baseline]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да