Back to results

High-Volume Vs Low-Volume Preparation in Emergency Department

Primary Purpose

GastroIntestinal Bleeding

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Low volume macrogol

High volume macrogol

About this trial

This is an interventional treatment trial for GastroIntestinal Bleeding

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

High-Volume

Low-Volume

Arm Description

Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy

Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy

Outcomes

Primary Outcome Measures

intestinal cleansing

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05362227

First Posted

April 29, 2022

Last Updated

April 1, 2023

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT05362227

Brief Title

High-Volume Vs Low-Volume Preparation in Emergency Department

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GastroIntestinal Bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-Volume

Arm Type

Other

Arm Description

Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy

Arm Title

Low-Volume

Arm Type

Other

Arm Description

Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy

Intervention Type

Drug

Intervention Name(s)

Low volume macrogol

Intervention Description

Clensia 2 lt

Intervention Type

Drug

Intervention Name(s)

High volume macrogol

Intervention Description

Selg 4 lt

Primary Outcome Measure Information:

Title

intestinal cleansing

Description

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

Time Frame

during colonscopy procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronica Ojetti, Prof

Organizational Affiliation

Fondazione Policlinico universitario a. Gemelli

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione Policlinico Universitario A. Gemelli IRCCS

City

Roma

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

High-Volume Vs Low-Volume Preparation in Emergency Department

We'll reach out to this number within 24 hrs