Skip to main content
Clinical Trials/NCT04310332
NCT04310332CompletedNot Applicable

1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.

IRCCS Azienda Ospedaliero-Universitaria di Bologna10 sites in 1 country1,004 target enrollmentStarted: February 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,004
Locations
10
Primary Endpoint
Overall colon cleansing efficacy

Study Overview

Brief Summary

Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported in an observational study among more than 1,000 inpatients. Thus, the present study is aimed at determining whether 1L-PEG outperforms 4L-PEG among inpatients, through a propensity score-matching between the two groups in order to correct for confounders.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.

Exclusion Criteria

  • patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)
  • patients who underwent bowel preparation outside the hospital

Arms & Interventions

1L-PEG

Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation.

Intervention: 1L-PEG (Drug)

4L-PEG

Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation.

Intervention: 4L-PEG (Drug)

Outcomes

Primary Outcomes

Overall colon cleansing efficacy

Time Frame: Outcome will be assessed during colonoscopy

Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)

Right colon cleansing efficacy

Time Frame: Outcome is assessed during colonoscopy

Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)

Secondary Outcomes

  • Safety (hematocrit change)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
  • Safety (serum creatinine imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
  • Safety (glomerular filtration rate change)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
  • Safety (serum sodium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
  • Safety (serum magnesium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
  • Safety (serum potassium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
  • Safety (serum calcium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Fuccio

Professor of Gastroenterology

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Sites (10)

Loading locations...

Similar Trials