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 Type
OBSERVATIONAL
Enrollment
1,004
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.
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.
Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Digestive Endoscopy Unit, Fondazione Poliambulanza
Brescia, Italy
UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena
Carpi, Italy
Gastroenterology Unit, Valduce Hospital
Como, Italy
Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna
Forlì, Italy
Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital
Iglesias, Italy
Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital
Milan, Italy
Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità
Novara, Italy
Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital
Piacenza, Italy
Gastroenterology Unit, S. Maria delle Croci Hospital
Ravenna, Italy
Overall colon cleansing efficacy
Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)
Time frame: Outcome will be assessed during colonoscopy
Right colon cleansing efficacy
Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)
Time frame: Outcome is assessed during colonoscopy
Safety (serum sodium imbalance)
Degree of serum sodium shift (mmol/L) before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum potassium imbalance)
Degree of serum potassium shift (mmol/L) before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum calcium imbalance)
Degree of serum calcium shift (mg/dL) before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum magnesium imbalance)
Degree of serum magnesium shift (mg/dL) before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum creatinine imbalance)
Degree of serum creatinine shift (mg/dL) before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (glomerular filtration rate change)
Degree of change in glomerular filtration rate (mL/min/1.73 m2), before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (hematocrit change)
Degree of change in hematocrit (%), before and after bowel preparation
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.