High-Volume Vs Low-Volume Preparation in Emergency Department

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

GastroIntestinal Bleeding

Treatments

Drug: Low volume macrogol
Drug: High volume macrogol

Study type

Interventional

Funder types

Other

Identifiers

NCT05362227
20192668

Details and patient eligibility

About

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.

Enrollment

228 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

228 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems