Bowel Preparation for Colonoscopy
Conditions
Keywords
lactulose, Colonoscopy, sodium phosphate, bowel preparation
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.
Interventions
COMBINATION_PRODUCTBowel 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_PRODUCTBowel 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.
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)
Intervention model description
Multicenter single-blind randomized clinical trial study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel Preparation Scale | 1 day | A total score of 6 or more, with no segment below 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico, Panama
Contacts
CONTACTRoberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C
Outcome results
None listed