High-Volume Vs Low-Volume Preparation in Emergency Department

Fondazione Policlinico Universitario Agostino Gemelli IRCCS228 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

228

Conditions

GastroIntestinal Bleeding

Interventions

Low volume macrogolDRUG

Clensia 2 lt

High volume macrogolDRUG

Selg 4 lt

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Outcomes

Primary Outcomes

intestinal cleansing

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

Time frame: during colonscopy procedure

Data from ClinicalTrials.gov

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