Bowel Preparation, Colonoscopy, Hospitalized Patients
Conditions
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.
Interventions
DRUG1L-PEG
The drug is 1L-PEG plus ascorbic acid (Plenvu®). It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy. Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational.
DRUG4L-PEG
The drug is 4L-PEG. It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy. Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall colon cleansing efficacy | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety (serum calcium imbalance) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of serum calcium shift (mg/dL) before and after bowel preparation |
| Safety (serum magnesium imbalance) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of serum magnesium shift (mg/dL) before and after bowel preparation |
| Safety (serum sodium imbalance) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of serum sodium shift (mmol/L) before and after bowel preparation |
| Safety (glomerular filtration rate change) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of change in glomerular filtration rate (mL/min/1.73 m2), before and after bowel preparation |
| Safety (hematocrit change) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of change in hematocrit (%), before and after bowel preparation |
| Safety (serum creatinine imbalance) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of serum creatinine shift (mg/dL) before and after bowel preparation |
| Safety (serum potassium imbalance) | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy | Degree of serum potassium shift (mmol/L) before and after bowel preparation |
Countries
Italy
Outcome results
None listed