Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.

NCT06666556 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 151/24
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial it is to bowel the instestinal preparation with lactulose vs poliethylenglicol as better agent to have a quality colonoscopy and demostrate that lactulose is most efective, has a good tolerance and the patient would have a better satisfaction, so the question is: wich is the eficancy of lactulose in comparision with thepoliethylenglycol in the intestinal preparation for the colonoscopy?

Conditions

Colorectal Cancer Screening

Keywords

colorectal; colorectal cancer; colorectal cancer screening; colonoscopy; polyethylenglycol; lactulose

Outcome Measures

Primary Outcomes (1)

• Score of the bowel cleaness

  It would be evaluated using a standardized scoring system, such as the BBPS scale.

  From date of randomization until the colonoscopy is done, assessed up to July 2025.

Secondary Outcomes (3)

• Tolerability

  From date of randomization until the colonoscopy is done, assessed up to July 2025.

• Gastrointestinal side effects

  From date of randomization until the colonoscopy is done, assessed up to July 2025.

• Patient Satisfaction and Palatability

  From date of randomization until the colonoscopy is done, assessed up to July 2025.

Study Arms (2)

Bowel preparation with lactulose before de colonoscopy

ACTIVE COMPARATOR

Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy

Combination Product: Bowel preparation before colonoscopy

Bowel preparation with plyethylenglycol before the colonoscopy

ACTIVE COMPARATOR

Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy

Combination Product: Bowel preparation before colonoscopy

Interventions

Bowel preparation before colonoscopy COMBINATION_PRODUCT

In this multicenter single-blind randomized clinical trial study we will provide each patient that meets our inclusion criteria a randomized folio to include them in one of both arms in our protocol, meaning one of the groups and the bowel preparation assigned to perform the colonoscopy, they will be explained the benefits and minimum risks of participating and they will also be asked to sign an informed consent form so we can continue with the colonoscopy and collect all the data we need for our protocol and the analysis of the variables.

Also known as: Lactulose

Bowel preparation with lactulose before de colonoscopy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication for colonoscopy in our coloproctology service
• Both women and men
• Patients within an age range of 18-79 years
• Patients who agree having a colonoscopy and who sign the informed consent to participate in the protocol

You may not qualify if:

• Patients under 18 or over 80 years old
• All patients that won´t like to participate in the protocol or won´t sign the informed consent
• Pregnant women
• Patients with a medical record of colonic resection, ostomy status, severe cardiopulmonary and renal diseases, major psychiatric disorders, therapeutic colonoscopy or any contraindications for colonoscopy
• Non compliance with the colonic preparation regimen
• Active bleeding during the procedure
• Patients with a known diagnosis of colorectal cancer

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (3)

Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44200, Mexico

RECRUITING

Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

IMSS Hospital General Regional 220 "José Vicente Villada"

México, Toluca de Lerdo, 50150, Mexico

RECRUITING

Related Publications (25)

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  BACKGROUND

• Lezama-de-Luna JF, Manrique MA, Chávez-García MÁ, Pérez-Corona T, Gómez-Peña-Alfaro NS, Pérez-Valle E, et al. Evaluación de la eficacia y tolerabilidad de tres esquemas de preparación de colon.

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• Sánchez-del-Río A, Pérez-Romero S, López-Picazo J, Alberca-de-las-Parras F, Júdez J, León-Molina J, et al. Indicadores de calidad en colonoscopia. Procedimiento de la colonoscopia. Rev Esp Enfermedades Dig. 2018;110(5):316-26.

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• Hammami A, Elloumi H, Bouali R, Elloumi H. Clinical practice standards for colonoscopy. Tunis Med. 2021 Octobre;99(10):952-960.

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• Cerna-Cardona J, Peláez-Luna MC, Casillas-Guzmán GB, Sánchez-Chávez X, Casanova-Lara AI, Espino-Cortés H, et al. Guía de endoscopia en enfermedad inflamatoria intestinal. Endoscopia. marzo de 2021;33(1):22-44.

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• Yamamoto-Furusho JK, Bosques-Padilla F, de-Paula J, Galiano MT, Ibanez P, Juliao F, Kotze PG, Rocha JL, Steinwurz F, Veitia G, Zaltman C. Diagnosis and treatment of inflammatory bowel disease: First Latin American Consensus of the Pan American Crohn's and Colitis Organisation. Rev Gastroenterol Mex. 2017 Jan-Mar;82(1):46-84. doi: 10.1016/j.rgmx.2016.07.003. Epub 2016 Dec 13. English, Spanish.

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• Rivero-Sanchez L, Pellise M. [Bowel preparation for colonoscopy. Any significant progress on the horizon?]. Gastroenterol Hepatol. 2015 Apr;38(4):287-300. doi: 10.1016/j.gastrohep.2014.10.008. Epub 2014 Dec 10. Spanish.

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  PMID: 23039803 BACKGROUND

Related Links

• La alucinante evolución de la endoscopia
• Historia de la Endoscopia

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lactulose; alginate-polyethylene glycol acrylate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Central Study Contacts

Roberto U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C

CONTACT

+52 3311946664; robertocruzneri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The main investigators will be in charge of randomizing all the patients ellegible for this protocol, and the care providers and endoscopists will be masked when it comes to knowing to which arm of the study each patient belongs to, untill the moment they need to perform the colonoscopy.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. C. Roberto Cruz Neri (Master in cience, medical staff Coloproctology Department Hospital Civil Fray Antonio Alcalde)

Model Details: multicenter single-blind randomized clinical trial study

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: July 20, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

ME (3)