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Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.

ConditionColorectal Cancer Screening
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-79
SponsorHospital Civil de Guadalajara

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bowel preparation before colonoscopy

    Combination product

    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 colonoscopy

    Combination product

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Bowel preparation with lactulose before de colonoscopyActive comparator 1 intervention
Group B: Bowel preparation with plyethylenglycol before the colonoscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Score of the bowel cleaness

It would be evaluated using a standardized scoring system, such as the BBPS scale.

Time frame
From date of randomization until the colonoscopy is done, assessed up to July 2025.

Secondary outcomes

1

Tolerability

Adverse symptoms and general tolerance of patients towards each bowel preparation will be recorded.

Time frame
From date of randomization until the colonoscopy is done, assessed up to July 2025.
2

Gastrointestinal side effects

Any gastrointestinal side effects experienced by patients during the bowel preparation process will be recorded.

Time frame
From date of randomization until the colonoscopy is done, assessed up to July 2025.
3

Patient Satisfaction and Palatability

Data will be collected on overall patient satisfaction and palatability of the agent with the bowel preparation process using a subjective rating scale.

Time frame
From date of randomization until the colonoscopy is done, assessed up to July 2025.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Civil de Guadalajara

Lead sponsor

Instituto Mexicano del Seguro Social

Collaborator

Source ClinicalTrials.gov
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