High-Volume Vs Low-Volume Preparation in Emergency Department

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.

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Key information

Conditions

Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Low volume macrogol

Drug

Clensia 2 lt

High volume macrogol

Drug

Selg 4 lt

Primary outcomes

intestinal cleansing

Time frame: during colonscopy procedure

Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: May 5, 2022
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed