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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
300
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.
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.
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico
RECRUITINGNuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, Mexico
NOT_YET_RECRUITINGHospital Gustavo Nelson Collado Ríos Panamá.
Panamá, Herrera Province, Panama
NOT_YET_RECRUITINGHospital Santo Tomas
Bella Vista, Provincia de Panamá, Panama
NOT_YET_RECRUITINGBoston Bowel Preparation Scale
A total score of 6 or more, with no segment below 2.
Time frame: 1 day
Hydroelectrolytic changes.
Number of patients with changes in blood concentrations of sodium, potassium, chloride, creatinine, and urea.
Time frame: Two blood drawns: During screening period and baseline visit.
Adverse gastrointestinal effects due to bowel preparation.
Number of patients experiencing adverse gastrointestinal effects, such as nausea, vomiting, or abdominal distension.
Time frame: Baseline.
Palatability
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.
Time frame: Baseline
Adenoma detection rate
Quantity and characteristics of adenomas detected during the colonoscopy.
Time frame: Baseline
Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C
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