High-Volume Vs Low-Volume Preparation in Emergency Department

GastroIntestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362227
• Other study ID #: 20192668
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Low volume macrogol
Clensia 2 lt
• High volume macrogol
Selg 4 lt

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intestinal cleansing	Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)	during colonscopy procedure