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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Bowel preparation with lactulose before de colonoscopy
description
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
interventionNames
Combination Product: Bowel preparation before colonoscopy
type
ACTIVE_COMPARATOR
label
Bowel preparation with plyethylenglycol before the colonoscopy
description
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
interventionNames
Combination Product: Bowel preparation before colonoscopy
Primary outcomes (1)
measure
Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS).
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Maximum age
79 Years
Show eligibility criteria text
* Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
References
Publications (25)
BACKGROUNDVarea-Calderón V, Martín de Carpi J. Videocolonoscopia: técnica e indicaciones. An Pediatría Contin. el 1 de febrero de 2008;6(1):42-4.
BACKGROUNDHerraiz 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. PMID 23218772
BACKGROUNDReumkens 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. PMID 27296945
BACKGROUNDPan 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. PMID 36158495
BACKGROUNDMartel 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. PMID 25863216
BACKGROUNDArenas 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.
BACKGROUNDLezama-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.
BACKGROUNDGaballa 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
timeFrame
The duration of the study (approximately 20 to 30 minutes).
description
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.
Secondary outcomes (3)
measure
Number of Participants With Gastrointestinal Side Effects
timeFrame
At the completion of bowel preparation, prior to colonoscopy (approximately 8 hours before the procedure).
description
Number of participants presenting gastrointestinal symptoms related to bowel preparation, including nausea, vomiting, abdominal pain, or abdominal distension.
measure
Number of Participants Who Tolerated the Assigned Bowel Preparation
timeFrame
24 hours before your colonoscopy
description
Tolerability was assessed through direct patient questioning after completion of bowel preparation. Participants were classified as having tolerated or not tolerated the assigned bowel preparation according to their overall subjective experience.
The analysis population consisted only of participants who completed the assigned bowel preparation and underwent colonoscopy. Participants excluded because of intolerance to the preparation were not included in this outcome analysis.
measure
Number of Participants Who Found the Bowel Preparation Palatable
timeFrame
24 hours before the colonoscopy while taking the assigned bowel preparation
description
Palatability was assessed by asking participants whether the taste of the assigned bowel preparation was acceptable. Participants were classified as having found the preparation palatable or not palatable based on their subjective response.
BACKGROUNDMurcio-Pérez E, Téllez-Ávila. F. Opciones de preparación para colonoscopia. Endoscopia. el 1 de enero de 2011;24(1):23-31.
BACKGROUNDIa I, Ma Á. Preparación intestinal para la colonoscopia en pacientes con diferentes patologías.
BACKGROUNDQuintero 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. PMID 23769425
BACKGROUNDMenacho 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. PMID 24676290
BACKGROUNDGrupo 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. PMID 29658767
BACKGROUNDHammami A, Elloumi H, Bouali R, Elloumi H. Clinical practice standards for colonoscopy. Tunis Med. 2021 Octobre;99(10):952-960. PMID 35288895
BACKGROUNDCerna-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.
BACKGROUNDYamamoto-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. PMID 27979414
BACKGROUNDKim 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. PMID 30670909
BACKGROUNDRamírez-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.
BACKGROUNDChurch 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. PMID 24267161
BACKGROUNDHong SM, Baek DH. A Review of Colonoscopy in Intestinal Diseases. Diagnostics (Basel). 2023 Mar 27;13(7):1262. doi: 10.3390/diagnostics13071262. PMID 37046479
BACKGROUNDLópez Rosés L, Olivencia Palomar P. Colonoscopia. Rev Esp Enfermedades Dig. junio de 2008;100(6):372-372.
BACKGROUNDAntoniou 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. PMID 22717798
BACKGROUNDTrujillo-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.
BACKGROUNDRivero-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. PMID 25499609
BACKGROUNDLorenzo-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. PMID 23039803