High-Volume Vs Low-Volume Preparation in Emergency Department

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

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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