Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
EII_Prep
1 other identifier
interventional
100
1 country
1
Brief Summary
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2021
CompletedJuly 23, 2021
May 1, 2020
2.4 years
July 24, 2019
July 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (2)
Treatment related adverse events
1 year
Preparation Tolerability: total volume of solution finally taken by the patient
1 year
Study Arms (3)
1L PEG
ACTIVE COMPARATOR2L PEG
ACTIVE COMPARATOR2L sodium picosulfate
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients between 18y and 90y
- Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario La Paz
Madrid, Madrd, 28046, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Dolores Martin Arranz, PhD
Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 24, 2019
First Posted
June 1, 2020
Study Start
February 1, 2019
Primary Completion
June 30, 2021
Study Completion
July 20, 2021
Last Updated
July 23, 2021
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share