Trial Title:
Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.
NCT ID:
NCT06666556
Condition:
Colorectal Cancer Screening
Conditions: Official terms:
Colorectal Neoplasms
Lactulose
Conditions: Keywords:
colorectal
colorectal cancer
colorectal cancer screening
colonoscopy
polyethylenglycol
lactulose
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
multicenter single-blind randomized clinical trial study
Primary purpose:
Screening
Masking:
Single (Care Provider)
Masking description:
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.
Intervention:
Intervention type:
Combination Product
Intervention name:
Bowel preparation before colonoscopy
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.
Arm group label:
Bowel preparation with lactulose before de colonoscopy
Other name:
Lactulose
Intervention type:
Combination Product
Intervention name:
Bowel preparation before colonoscopy
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.
Arm group label:
Bowel preparation with plyethylenglycol before the colonoscopy
Other name:
Polyethylenglycol
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?
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.
Criteria for eligibility:
Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Address:
City:
Guadalajara
Zip:
44200
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Roberto U Cruz Neri, M. C.
Phone:
+52 3311946664
Email:
robertocruzneri@gmail.com
Contact backup:
Email:
robertocruzneri@gmail.com
Contact backup:
Last name:
Luis A. Ruiz Mares, M. C.
Contact backup:
Last name:
Francisco J. Valadez Correa, M. C.
Contact backup:
Last name:
Jose A. González Duarte, M. C.
Contact backup:
Last name:
Florissa Hernández Gomez, M. C.
Contact backup:
Last name:
Milton M. Salas Nuñez, M. C.
Facility:
Name:
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Address:
City:
Guadalajara
Zip:
44340
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Jesús A Valenzuela Pérez, M. C.
Phone:
+52 3331497976
Email:
dr_jvalenzuela@hotmail.com
Contact backup:
Last name:
Jesús A. Valenzuela Pérez, M. C.
Facility:
Name:
IMSS Hospital General Regional 220 "José Vicente Villada"
Address:
City:
Mexico
Zip:
50150
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Carlos H Sandoval Jiménez, M. C.
Phone:
+52 7225121556
Email:
drmasaju@gmail.com
Contact backup:
Last name:
Carlos H. Sandoval Jiménez, M. C.
Phone:
+52 7225121556
Email:
drmasaju@gmail.com
Contact backup:
Last name:
Carlos H. Sandoval Jiménez, M. C.
Start date:
July 20, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Hospital Civil de Guadalajara
Agency class:
Other
Collaborator:
Agency:
Instituto Mexicano del Seguro Social
Agency class:
Other
Source:
Hospital Civil de Guadalajara
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666556
http://www.revistagastroenterologiamexico.org/es-pdf-X0375090601252936
https://www.amegendoscopia.org.mx/index.php/acerca/historia/145-historia-de-la-endoscopia
