High-Volume Vs Low-Volume Preparation in Emergency Department

Not Applicable

Completed

• Conditions: GastroIntestinal Bleeding
• Interventions: Drug: High volume macrogol; Drug: Low volume macrogol

• Registration Number: NCT05362227
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30
• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-01
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Volume	High volume macrogol	Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy
Low-Volume	Low volume macrogol	Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy