Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease (EII_Prep)

July 22, 2021 updated by: María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrd
      • Madrid, Madrd, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 18y and 90y
  • Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy

Exclusion Criteria:

  • Patients <18y or >90y
  • Pregnant Women
  • Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study
  • Patients with a history of bowel resection
  • Patients undergoing therapeutic colonoscopy
  • Patients unable to understand study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1L PEG
Procedure: Endoscopy
Colonoscopy
Active Comparator: 2L PEG
Procedure: Endoscopy
Colonoscopy
Active Comparator: 2L sodium picosulfate
Procedure: Endoscopy
Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel cleansing
Time Frame: 1 year
Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related adverse events
Time Frame: 1 year
Number of Participants with symptomatology related to intervention in each arm of the study
1 year
Preparation Tolerability: total volume of solution finally taken by the patient
Time Frame: 1 year
Evaluation of total volume of solution finally taken by the patient
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Investigators

  • Principal Investigator: Maria Dolores Martin Arranz, PhD, Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 20, 2021

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EII_Prep

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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