High-Volume Vs Low-Volume Preparation in Emergency Department
Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy
1 other identifier
interventional
228
1 country
1
Brief Summary
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS). The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
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
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
April 29, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedApril 4, 2023
April 1, 2023
1.6 years
April 29, 2022
April 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
intestinal cleansing
Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)
during colonscopy procedure
Study Arms (2)
High-Volume
OTHERPatients in the group were instructed to take 4 L of solution on the day before the colonoscopy
Low-Volume
OTHERPatients in the group were instructed to take 2 L of solution on the day before the colonoscopy
Interventions
Eligibility Criteria
You may qualify if:
- males or females
- \> 18 years and \<85 years,
- hemodynamically stable,
- able to sign informed consent
- requiring colonoscopy
- anemia (loss of at least 2 g/dl of Hb) with or without active bleeding
You may not qualify if:
- suspected or confirmed pregnancy,
- hemodynamically unstable patients,
- patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation,
- toxic megacolon,
- major colonic resection,
- heart failure (Class III or IV NYHA),
- severe liver failure,
- end-stage renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
Related Publications (1)
Saviano A, Petruzziello C, Riccioni ME, Di Pumpo M, Petrucci M, Brigida M, Zanza C, Candelli M, Franceschi F, Ojetti V. Lower Gastrointestinal Bleeding in the Emergency Department: High- Volume vs. Low-Volume Peg Bowel Preparation for Colonoscopy: A Randomized Trial. Rev Recent Clin Trials. 2023;18(1):76-81. doi: 10.2174/1574887117666220908152754.
PMID: 36089784DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronica Ojetti, Prof
Fondazione Policlinico universitario a. Gemelli
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 29, 2022
First Posted
May 5, 2022
Study Start
November 1, 2019
Primary Completion
May 30, 2021
Study Completion
June 30, 2021
Last Updated
April 4, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share