High-Volume Vs Low-Volume Preparation in Emergency Department

April 1, 2023 updated by: OJETTI VERONICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: during colonscopy procedure
Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)
during colonscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Veronica Ojetti, Prof, Fondazione Policlinico Universitario A. Gemelli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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