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CompletedNCT05362227Updated Apr 4, 2023

High-Volume Vs Low-Volume Preparation in Emergency Department

An interventional study of Low volume macrogol and High volume macrogol in GastroIntestinal Bleeding, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Nov 2019, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • GastroIntestinal Bleeding
03

In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's enrollment of 228 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
228 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugLow volume macrogol

    Clensia 2 lt

  • DrugHigh volume macrogol

    Selg 4 lt

06

What researchers measure

Primary outcomes

  1. intestinal cleansing

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

    Time frame: during colonscopy procedure

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05362227
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
OJETTI VERONICA (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
May 5, 2022
Start date
Nov 1, 2019
Primary completion
May 30, 2021
Completion
Jun 30, 2021
Last update
Apr 4, 2023

Study contacts

Veronica Ojetti, Prof
principal investigator · Fondazione Policlinico universitario a. Gemelli

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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