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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intestinal preparation using sodium phosphate | Active Comparator | Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date. |
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| Bowel preparation with lactulose | Active Comparator | Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bowel preparation before colonoscopy: Lactulose. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale | A total score of 6 or more, with no segment below 2. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Hydroelectrolytic changes. | Number of patients with changes in blood concentrations of sodium, potassium, chloride, creatinine, and urea. | Two blood drawns: During screening period and baseline visit. |
| Adverse gastrointestinal effects due to bowel preparation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C | Contact | +52 3311946664 | robertocruzneri@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Recruiting | Guadalajara | Jalisco | 44200 | Mexico |
The participants'/patients' data will be recorded only by hospital record and coded ID in the study database, no personal information wil be recorded. If necessary, additional data that may be used in the database will also be considered.
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Multicenter single-blind randomized clinical trial study.
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| Bowel preparation before colonoscopy: Sodium phosphate. | 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. |
|
Number of patients experiencing adverse gastrointestinal effects, such as nausea, vomiting, or abdominal distension. |
| 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. | Baseline |
| Adenoma detection rate | Quantity and characteristics of adenomas detected during the colonoscopy. | Baseline |
| Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca" | Not yet recruiting | Guadalajara | Jalisco | 44340 | Mexico |
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| Hospital Gustavo Nelson Collado Ríos Panamá. | Not yet recruiting | Panamá | Herrera Province | Panama |
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| Hospital Santo Tomas | Not yet recruiting | Bella Vista | Provincia de Panamá | 37 | Panama |
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