Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-20

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter single-blind randomized clinical trial study.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intestinal preparation using sodium phosphate

Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date.

Group Type ACTIVE_COMPARATOR

Bowel preparation before colonoscopy: Sodium phosphate.

Intervention Type COMBINATION_PRODUCT

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 protocol and variable analysis.

Bowel preparation with lactulose

Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date.

Group Type ACTIVE_COMPARATOR

Bowel preparation before colonoscopy: Lactulose.

Intervention Type COMBINATION_PRODUCT

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 protocol and variable analysis.

Interventions

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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 protocol and variable analysis.

Intervention Type COMBINATION_PRODUCT

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 protocol and variable analysis.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes