Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.

Not Applicable

Not yet recruiting

• Conditions: Bowel Preparation for Colonoscopy

• Registration Number: NCT07060222
• Lead Sponsor: Hospital Civil de Guadalajara

Brief 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.

Study Timeline

• Study First Submitted: 2025-06-11
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-08
• Study First Posted: 2025-07-11
• Last Update Submitted: 2025-07-17
• Study Start: 2025-07-20
• Last Update Posted: 2025-07-22
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale	1 day	A total score of 6 or more, with no segment below 2.

Secondary Outcome Measures

Name	Time	Method
Hydroelectrolytic changes.	Two blood drawns: During screening period and baseline visit.	Number of patients with changes in blood concentrations of sodium, potassium, chloride, creatinine, and urea.
Adverse gastrointestinal effects due to bowel preparation.	Baseline.	Number of patients experiencing adverse gastrointestinal effects, such as nausea, vomiting, or abdominal distension.
Palatability	Baseline	Number of patients experiencing changes in taste sensation during bowel preparation intake and its aftertaste: Sweet, salty, bitter, sour. Scale 1-5: low; 5-10: high.
Adenoma detection rate	Baseline	Quantity and characteristics of adenomas detected during the colonoscopy.

Trial Locations

Locations (4)

Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"; 🇲🇽 Guadalajara, Jalisco, Mexico

Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"; 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Gustavo Nelson Collado Ríos Panamá.; 🇵🇦 Panamá, Provincia de Herrera, Panama

Hospital Santo Tomas; 🇵🇦 Bella vista, Panama