1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.
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
Lorenzo Fuccio
Professor of Gastroenterology
IRCCS Azienda Ospedaliero-Universitaria di Bologna