Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 8:42 AM
Study NCT ID:
NCT06666556
Status:
RECRUITING
Last Update Posted:
2024-10-30
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007792', 'term': 'Lactulose'}, {'id': 'C557319', 'term': 'alginate-polyethylene glycol acrylate'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter single-blind randomized clinical trial study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of the bowel cleaness', 'timeFrame': 'From date of randomization until the colonoscopy is done, assessed up to July 2025.', 'description': 'It would be evaluated using a standardized scoring system, such as the BBPS scale.'}], 'secondaryOutcomes': [{'measure': 'Tolerability', 'timeFrame': 'From date of randomization until the colonoscopy is done, assessed up to July 2025.', 'description': 'Adverse symptoms and general tolerance of patients towards each bowel preparation will be recorded.'}, {'measure': 'Gastrointestinal side effects', 'timeFrame': 'From date of randomization until the colonoscopy is done, assessed up to July 2025.', 'description': 'Any gastrointestinal side effects experienced by patients during the bowel preparation process will be recorded.'}, {'measure': 'Patient Satisfaction and Palatability', 'timeFrame': 'From date of randomization until the colonoscopy is done, assessed up to July 2025.', 'description': 'Data will be collected on overall patient satisfaction and palatability of the agent with the bowel preparation process using a subjective rating scale.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['colorectal', 'colorectal cancer', 'colorectal cancer screening', 'colonoscopy', 'polyethylenglycol', 'lactulose'], 'conditions': ['Colorectal Cancer Screening']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Varea-Calderón V, Martín de Carpi J. Videocolonoscopia: técnica e indicaciones. An Pediatría Contin. el 1 de febrero de 2008;6(1):42-4.'}, {'pmid': '23218772', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27296945', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36158495', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25863216', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': 'Murcio-Pérez E, Téllez-Ávila. F. Opciones de preparación para colonoscopia. Endoscopia. el 1 de enero de 2011;24(1):23-31.'}, {'type': 'BACKGROUND', 'citation': 'Ia I, Ma Á. Preparación intestinal para la colonoscopia en pacientes con diferentes patologías.'}, {'pmid': '23769425', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24676290', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35288895', 'type': 'BACKGROUND', 'citation': 'Hammami A, Elloumi H, Bouali R, Elloumi H. Clinical practice standards for colonoscopy. Tunis Med. 2021 Octobre;99(10):952-960.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27979414', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '30670909', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24267161', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37046479', 'type': 'BACKGROUND', 'citation': 'Hong SM, Baek DH. A Review of Colonoscopy in Intestinal Diseases. Diagnostics (Basel). 2023 Mar 27;13(7):1262. doi: 10.3390/diagnostics13071262.'}, {'type': 'BACKGROUND', 'citation': 'López Rosés L, Olivencia Palomar P. Colonoscopia. Rev Esp Enfermedades Dig. junio de 2008;100(6):372-372.'}, {'pmid': '22717798', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25499609', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23039803', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.revistagastroenterologiamexico.org/es-pdf-X0375090601252936', 'label': 'La alucinante evolución de la endoscopia'}, {'url': 'https://www.amegendoscopia.org.mx/index.php/acerca/historia/145-historia-de-la-endoscopia', 'label': 'Historia de la Endoscopia'}]}, 'descriptionModule': {'briefSummary': '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:\n\nwich is the eficancy of lactulose in comparision with thepoliethylenglycol in the intestinal preparation for the colonoscopy?', 'detailedDescription': 'A bowel preparation is fundamental before making a colonoscopy, letting us realize a correct exploration in all the bowel. The main method of cleaning would be fast, safe and getting a high grade of visualizing to do a quality colonoscopy.\n\nActually there are a lot of methods or products of cleaning the bowel. A good cleaning have a lot of successful choosing a good product to do it and having a good diet before the colonoscopy.\n\nThere are a lot of scales about the cleaning in the colonoscopy, having a good bowel preparation increase the capacity of the detection of polyps, decrease the time of the colonoscopy and getting better the cost and efficiency.\n\nThe colonoscopy plays a crucial role in the screening and treatment of colorectal cancer. It is an optimal procedure to identify precancerous lesions. polyps and recommended for screening people with risk factors, such as a family history of polyps or cancer.\n\nBowel preparation is a crucial aspect in colonoscopy due to its direct relationship with the quality of the procedure. Many patients find bowel preparation to be the most uncomfortable part of the examination, so ensuring that it is safe, extremely efficient, reliable, convenient and tolerable enough to ensure that patients will not be able to complete it or wish to undergo future procedures, associating this with the bad taste of the agents used and the adverse events produced.\n\nIgnorance of the importance of adequate bowel preparation and cleansing explains poor adherence to instructions, and increases the rate of inadequate bowel preparation.\n\nThe health team must provide correct and clear information that improves patient adherence. The importance of compliance with the indications and the impact of adequate intestinal cleansing on the findings and results of colonoscopy should be emphasized.\n\nThe cleaning systems used in colonoscopy must allow more than 90% of the mucosal surface to be explored. Furthermore, the drugs used must be well tolerated by the patient and not cause side effects. Therefore, the ideal colonoscopy preparation should combine efficacy, excellent tolerance, and minimal adverse effects.\n\nThe use of oral bowel preparations may induce strong peristalsis, cramps, bloating, diarrhea and other symptoms. Intolerance to the preparation is common and is usually associated with the volume of liquid consumed and the taste of the solution.\n\nPolyethyleneglycol (Muvinlax(r) or Nulytely is a non-absorbable electrolyte solution and does not induce electrolyte mucus secretion or significantly reduce fluid exchange in the colonic lumen. It has been shown to be non-toxic and can be ingested in large quantities without dangerous effects. Its use is relatively safe in patients with kidney failure, cirrhosis or congestive heart failure.\n\nBowel preparation with polyethyleneglycol represents the most used formula in our environment. Among the recognized limitations associated with its application are: the large amount of volume to be ingested (4 L), which makes it impossible to administer it to elderly people with swallowing difficulties, it is also poorly tolerated by patients and has been associated with medical complications, among which can be mentioned: vomiting, abdominal distension, abdominal pain, nausea, Mallory Weiss syndrome, esophageal perforation, bronchoaspiration, toxic colitis, pancreatitis induced by polyethyleneglycol.\n\nLactulose (Duphalac (r)) is a disaccharide, semi-synthetic derivative of lactulose. It is absorbed and undergoes bacterial action, which causes fermentation, acidifying the environment and causing acceleration of intestinal transit, stimulating motility. Another consequence of acidification is the increase in osmotic pressure within the lumen of the colon, proportional to the dose. Regarding the dose, 120 ml are diluted with juice or clear water until completing 1000 ml, swallowing the entire volume in 1 hour The preparation regimen has a significant impact on the quality of intestinal cleansing. Traditionally, preparation is done one day before a colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n* Patients with indication for colonoscopy in our coloproctology service\n* Both women and men\n* Patients within an age range of 18-79 years\n* Patients who agree having a colonoscopy and who sign the informed consent to participate in the protocol\n\nExclusion Criteria:\n\n* Patients under 18 or over 80 years old\n* All patients that won´t like to participate in the protocol or won´t sign the informed consent\n* Pregnant women\n* 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\n* Non compliance with the colonic preparation regimen\n* Active bleeding during the procedure\n* Patients with a known diagnosis of colorectal cancer'}, 'identificationModule': {'nctId': 'NCT06666556', 'briefTitle': 'Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.', 'orgStudyIdInfo': {'id': '151/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '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']}], 'interventions': [{'name': 'Bowel preparation before colonoscopy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Lactulose'], 'description': '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.', 'armGroupLabels': ['Bowel preparation with lactulose before de colonoscopy']}, {'name': 'Bowel preparation before colonoscopy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Polyethylenglycol'], 'description': '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.', 'armGroupLabels': ['Bowel preparation with plyethylenglycol before the colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44200', 'city': 'Guadalajara', 'state': 'Jalisco', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Roberto U Cruz Neri, M. C.', 'role': 'CONTACT', 'email': 'robertocruzneri@gmail.com', 'phone': '+52 3311946664'}, {'role': 'CONTACT', 'email': 'robertocruzneri@gmail.com'}, {'name': 'Luis A. Ruiz Mares, M. C.', 'role': 'CONTACT'}, {'name': 'Francisco J. Valadez Correa, M. C.', 'role': 'CONTACT'}, {'name': 'Jose A. González Duarte, M. C.', 'role': 'CONTACT'}, {'name': 'Florissa Hernández Gomez, M. C.', 'role': 'CONTACT'}, {'name': 'Milton M. Salas Nuñez, M. C.', 'role': 'CONTACT'}], 'facility': 'Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Jesús A Valenzuela Pérez, M. C.', 'role': 'CONTACT', 'email': 'dr_jvalenzuela@hotmail.com', 'phone': '+52 3331497976'}, {'name': 'Jesús A. Valenzuela Pérez, M. C.', 'role': 'CONTACT'}], 'facility': 'Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '50150', 'city': 'México', 'state': 'Toluca de Lerdo', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Carlos H Sandoval Jiménez, M. C.', 'role': 'CONTACT', 'email': 'drmasaju@gmail.com', 'phone': '+52 7225121556'}, {'name': 'Carlos H. Sandoval Jiménez, M. C.', 'role': 'CONTACT', 'email': 'drmasaju@gmail.com', 'phone': '+52 7225121556'}, {'name': 'Carlos H. Sandoval Jiménez, M. C.', 'role': 'CONTACT'}], 'facility': 'IMSS Hospital General Regional 220 "José Vicente Villada"', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'centralContacts': [{'name': 'Roberto U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C', 'role': 'CONTACT', 'email': 'robertocruzneri@gmail.com', 'phone': '+52 3311946664'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M. C. Roberto Cruz Neri (Master in cience, medical staff Coloproctology Department Hospital Civil Fray Antonio Alcalde)', 'investigatorFullName': 'Roberto Ulises Cruz Neri', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}