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
-
-
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
|
Colonoscopy
|
|
Active Comparator: 2L PEG
|
Colonoscopy
|
|
Active Comparator: 2L sodium picosulfate
|
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
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.