NCT07060222

Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Bowel Preparation for Colonoscopy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
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.

Timeline

• Start date: 2025-07-20
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2025-07-11
• Last updated: 2025-07-22

Locations

4 sites across 2 countries: Mexico, Panama

Regulatory

• FDA-regulated drug study
• FDA-regulated device study