NCT06666556|CompletedPhase 4ResultsDMCFDA DrugFDA Device
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Sponsor study identifier
interventional
449
1 country
3
Study Start
July 20, 2024
Actual (reported)Primary Completion
July 31, 2025
Actual (reported)Study Completion
August 14, 2025
Actual (reported)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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 14, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2024
Actual (reported)October 28, 2024
Actual (reported)October 30, 2024
Actual (reported)July 31, 2025
Actual (reported)August 14, 2025
Actual (reported)July 28, 2026
Actual (reported)Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS).
Bowel cleansing quality was assessed using the Boston Bowel Preparation Scale (BBPS), which evaluates three segments of the colon (right, transverse, and left), each scored from 0 to 3, with a total score ranging from 0 to 9. Higher scores indicate better bowel preparation.
The duration of the study (approximately 20 to 30 minutes).
Number of Participants With Gastrointestinal Side Effects
At the completion of bowel preparation, prior to colonoscopy (approximately 8 hours before the procedure).
Number of Participants Who Tolerated the Assigned Bowel Preparation
24 hours before your colonoscopy
Number of Participants Who Found the Bowel Preparation Palatable
24 hours before the colonoscopy while taking the assigned bowel preparation
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
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.
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44200, Mexico
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, 44340, Mexico
IMSS Hospital General Regional 220 "José Vicente Villada"
México, Toluca de Lerdo, 50150, Mexico
Varea-Calderón V, Martín de Carpi J. Videocolonoscopia: técnica e indicaciones. An Pediatría Contin. el 1 de febrero de 2008;6(1):42-4.
Herraiz M. [Colonoscopy with carbon dioxide insufflation: luxury or neccesity?]. Gastroenterol Hepatol. 2013 Jan;36(1):43-7. doi: 10.1016/j.gastrohep.2012.06.002. Epub 2012 Dec 4. Spanish.
Reumkens A, Rondagh EJ, Bakker CM, Winkens B, Masclee AA, Sanduleanu S. Post-Colonoscopy Complications: A Systematic Review, Time Trends, and Meta-Analysis of Population-Based Studies. Am J Gastroenterol. 2016 Aug;111(8):1092-101. doi: 10.1038/ajg.2016.234. Epub 2016 Jun 14.
Each teaching hospital, like those already mentioned, employs different methods of practice, study, and patient diversity, and has its own specific indications for colonoscopies, whether for diagnosis or screening. This also includes the anesthetic methods, the trainees, resident physicians, and attending physicians responsible for their respective services. It's also important to mention the colonoscopy equipment at each hospital, including its operation, cleaning, and maintenance.
449 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2024
First Posted
October 30, 2024
EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Pan H, Zheng XL, Fang CY, Liu LZ, Chen JS, Wang C, Chen YD, Huang JM, Zhou YS, He LP. Same-day single-dose vs large-volume split-dose regimens of polyethylene glycol for bowel preparation: A systematic review and meta-analysis. World J Clin Cases. 2022 Aug 6;10(22):7844-7858. doi: 10.12998/wjcc.v10.i22.7844.
Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8.
Arenas M, Pérez-Arellano E. Colonoscopy preparations: electrolyte imbalances and precautions in the fragile patients. Rev Andal Patol Dig. el 30 de abril de 2024;47(2):66-71.
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.
Gaballa S, Naguib Y, Mady F, Khaled K. Polyethylene glycol: Properties, applications, and challenges. J Adv Biomed Pharm Sci. el 21 de diciembre de 2023;0(0):26-36
Murcio-Pérez E, Téllez-Ávila. F. Opciones de preparación para colonoscopia. Endoscopia. el 1 de enero de 2011;24(1):23-31.
Ia I, Ma Á. Preparación intestinal para la colonoscopia en pacientes con diferentes patologías.
Quintero E, Alarcon-Fernandez O, Jover R. [Colonoscopy quality control as a requirement of colorectal cancer screening]. Gastroenterol Hepatol. 2013 Nov;36(9):597-605. doi: 10.1016/j.gastrohep.2013.02.005. Epub 2013 Jun 12. Spanish.
Menacho AM, Reimann A, Hirata LM, Ganzerella C, Ivano FH, Sugisawa R. Double-blind prospective randomized study comparing polyethylene glycol to lactulose for bowel preparation in colonoscopy. Arq Bras Cir Dig. 2014 Jan-Mar;27(1):9-12. doi: 10.1590/s0102-67202014000100003.
Grupo de Trabajo de "Indicadores de calidad en endoscopia" de la Sociedad Espanola de Patologia Digestiva (SEPD). Quality indicators in colonoscopy. The colonoscopy procedure. Rev Esp Enferm Dig. 2018 May;110(5):316-326. doi: 10.17235/reed.2018.5408/2017.
Hammami A, Elloumi H, Bouali R, Elloumi H. Clinical practice standards for colonoscopy. Tunis Med. 2021 Octobre;99(10):952-960.
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.
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.
Kim SY, Kim HS, Park HJ. Adverse events related to colonoscopy: Global trends and future challenges. World J Gastroenterol. 2019 Jan 14;25(2):190-204. doi: 10.3748/wjg.v25.i2.190.
Ramírez-Quesada W, Vargas-Madrigal J, Alfaro-Murillo O, Umaña-Solís E, Campos-Goussen C, Alvarado-Salazar M, et al. Indicadores de calidad para la realización de colonoscopia. Acta Médica Costarric. marzo de 2019;61(1):37-42.
Church J. Colonoscopy: what are we missing? Surg Oncol Clin N Am. 2014 Jan;23(1):1-9. doi: 10.1016/j.soc.2013.09.001. Epub 2013 Nov 1.
Hong SM, Baek DH. A Review of Colonoscopy in Intestinal Diseases. Diagnostics (Basel). 2023 Mar 27;13(7):1262. doi: 10.3390/diagnostics13071262.
López Rosés L, Olivencia Palomar P. Colonoscopia. Rev Esp Enfermedades Dig. junio de 2008;100(6):372-372.
Antoniou SA, Antoniou GA, Koutras C, Antoniou AI. Endoscopy and laparoscopy: a historical aspect of medical terminology. Surg Endosc. 2012 Dec;26(12):3650-4. doi: 10.1007/s00464-012-2389-y. Epub 2012 Jun 21.
Trujillo-Benavides O, Solana-Sentíes S, Aguilar-Mendoza J, Angulo-Molina D, Barrera-Torres H, Barreto-Zúñiga R, et al. Guía clínica de calidad en colonoscopia y polipectomía. Endoscopia. junio de 2021;33(2):54-74.
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.
Lorenzo-Zuniga V, Moreno-de-Vega V, Boix J. [Preparation for colonoscopy: types of scales and cleaning products]. Rev Esp Enferm Dig. 2012 Aug;104(8):426-31. doi: 10.4321/s1130-01082012000800006. Spanish.
Study Start
July 20, 2024
Actual (reported)Primary Completion
July 31, 2025
Actual (reported)Study Completion
August 14, 2025
Actual (reported)Last Updated
July 28, 2026
Results First Posted
July 28, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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