Colorectal Cancer ScreeningPhase 4NCT06666556
Bowel Preparation in Colonoscopy: Lactulose vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.
A Phase 4 study testing Bowel preparation before colonoscopy in people with Colorectal Cancer Screening, run by Hospital Civil de Guadalajara at 3 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Bowel preparation before colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 3 sitesMexico
- Study dates
- 20 Jul 2024to 14 Aug 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44200
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, 44340
IMSS Hospital General Regional 220 "José Vicente Villada"
México, Toluca de Lerdo, 50150
About this study
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?
Read the detailed description
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.
Actually 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.
There 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.
The 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.
Bowel 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.
Ignorance of the importance of adequate bowel preparation and cleansing explains poor adherence to instructions, and increases the rate of inadequate bowel preparation.
The 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.
The 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.
The 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.
Polyethyleneglycol (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.
Bowel 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.
Lactulose (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.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Bowel preparation before colonoscopy
- Keywords
- colorectal, colorectal cancer, colorectal cancer screening, colonoscopy, polyethylenglycol, lactulose
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel preparation before colonoscopyCombination product
Also called Lactulose
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.
Bowel preparation before colonoscopyCombination product
Also called Polyethylenglycol
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Combination Product: Bowel preparation before colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The duration of the study (approximately 20 to 30 minutes).
Secondary outcomes (3)
Number of Participants With Gastrointestinal Side Effects
Number of participants presenting gastrointestinal symptoms related to bowel preparation, including nausea, vomiting, abdominal pain, or abdominal distension.
Measured: At the completion of bowel preparation, prior to colonoscopy (approximately 8 hours before the procedure).
Number of Participants Who Tolerated the Assigned Bowel Preparation
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.
Measured: 24 hours before your colonoscopy
Number of Participants Who Found the Bowel Preparation Palatable
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.
Measured: 24 hours before the colonoscopy while taking the assigned bowel preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start20 Jul 2024
- Primary completion31 Jul 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter single-blind randomized clinical trial study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, Roberto Ulises Cruz Neri, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666556
- Sponsor's protocol ID
- 151/24
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
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.
PubMed 23218772Reumkens 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.
PubMed 27296945Pan 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.
PubMed 36158495Martel 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.
PubMed 25863216Arenas 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.
PubMed 23769425Menacho 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.
PubMed 24676290Grupo 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.
PubMed 29658767Hammami A, Elloumi H, Bouali R, Elloumi H. Clinical practice standards for colonoscopy. Tunis Med. 2021 Octobre;99(10):952-960.
PubMed 35288895Cerna-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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation in Colonoscopy: Lactulose vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.
- ClinicalTrials.gov ID
- NCT06666556
- Acronym / sponsor ID
- 151/24
- Conditions
- Colorectal Cancer Screening
- Keywords
- colorectal, colorectal cancer, colorectal cancer screening, colonoscopy, polyethylenglycol, lactulose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Actually 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.
There 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.
The 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.
Bowel 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.
Ignorance of the importance of adequate bowel preparation and cleansing explains poor adherence to instructions, and increases the rate of inadequate bowel preparation.
The 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.
The 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.
The 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.
Polyethyleneglycol (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.
Bowel 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.
Lactulose (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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- multicenter single-blind randomized clinical trial study
| Arm | Type | Receives |
|---|---|---|
| Bowel preparation with lactulose before de colonoscopy | Active comparator | Combination Product: Bowel preparation before colonoscopyPatients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy |
| Bowel preparation with plyethylenglycol before the colonoscopy | Active comparator | Combination Product: Bowel preparation before colonoscopyPatients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel preparation before colonoscopyAlso: LactuloseIn 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. | Combination product | Bowel preparation with lactulose before de colonoscopy |
| Bowel preparation before colonoscopyAlso: PolyethylenglycolIn 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. | Combination product | Bowel preparation with plyethylenglycol before the colonoscopy |
Primary outcome
Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS).
Time frame: The duration of the study (approximately 20 to 30 minutes).
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.
3 secondary outcomes
Number of Participants With Gastrointestinal Side Effects
Time frame: At the completion of bowel preparation, prior to colonoscopy (approximately 8 hours before the procedure).
Number of Participants Who Tolerated the Assigned Bowel Preparation
Time frame: 24 hours before your colonoscopy
Number of Participants Who Found the Bowel Preparation Palatable
Time frame: 24 hours before the colonoscopy while taking the assigned bowel preparation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundVarea-Calderón V, Martín de Carpi J. Videocolonoscopia: técnica e indicaciones. An Pediatría Contin. el 1 de febrero de 2008;6(1):42-4.
- Background: PubMed 23218772Herraiz 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.
- Background: PubMed 27296945Reumkens 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.
- Background: PubMed 36158495Pan 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.
- Background: PubMed 25863216Martel 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.
- 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
- 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.
- Background: PubMed 23769425Quintero 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.
- Background: PubMed 24676290Menacho 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.
- La alucinante evolución de la endoscopiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bowel preparation before colonoscopy in people with Colorectal Cancer Screening, run by Hospital Civil de Guadalajara at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS). (time frame: The duration of the study (approximately 20 to 30 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06666556, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.