Back to resultsProtocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease (EII_Prep)
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Colonoscopy, Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1L PEG
2L PEG
2L sodium picosulfate
Arm Description
Outcomes
Primary Outcome Measures
Bowel cleansing
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.
Secondary Outcome Measures
Treatment related adverse events
Number of Participants with symptomatology related to intervention in each arm of the study
Preparation Tolerability: total volume of solution finally taken by the patient
Evaluation of total volume of solution finally taken by the patient
Full Information
NCT ID
NCT04411017
First Posted
July 24, 2019
Last Updated
July 22, 2021
Sponsor
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT04411017
Brief Title
Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
Acronym
EII_Prep
Official Title
Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Colonoscopy, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1L PEG
Arm Type
Active Comparator
Arm Title
2L PEG
Arm Type
Active Comparator
Arm Title
2L sodium picosulfate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopy
Intervention Description
Colonoscopy
Primary Outcome Measure Information:
Title
Bowel cleansing
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Treatment related adverse events
Description
Number of Participants with symptomatology related to intervention in each arm of the study
Time Frame
1 year
Title
Preparation Tolerability: total volume of solution finally taken by the patient
Description
Evaluation of total volume of solution finally taken by the patient
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Dolores Martin Arranz, PhD
Organizational Affiliation
Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
State/Province
Madrd
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
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