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

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 Overview

• Status: Completed
• Conditions: GastroIntestinal Bleeding
• Intervention / Treatment: Drug: High volume macrogol; Drug: Low volume macrogol

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: High-Volume; Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy	Drug: High volume macrogol; Selg 4 lt
Other: Low-Volume; Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy	Drug: Low volume macrogol; Clensia 2 lt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intestinal cleansing	Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)	during colonscopy procedure

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Veronica Ojetti, Prof, Fondazione Policlinico Universitario A. Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Emergencies; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 20192668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No