Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1L-PEG | Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation. |
| |
| 4L-PEG | Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1L-PEG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall colon cleansing efficacy | Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment) | 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) | Outcome is assessed during colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (serum sodium imbalance) | Degree of serum sodium shift (mmol/L) before and after bowel preparation | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy |
| Safety (serum potassium imbalance) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Hospitalized patients who are scheduled a colonoscopy as inpatients.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Sant'Orsola-Malpighi | Bologna | Italy | ||||
| Digestive Endoscopy Unit, Fondazione Poliambulanza |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33250131 | Derived | Frazzoni L, Spada C, Radaelli F, Mussetto A, Laterza L, La Marca M, Piccirelli S, Cortellini F, Rondonotti E, Paci V, Bazzoli F, Fabbri C, Manno M, Aragona G, Manes G, Occhipinti P, Cadoni S, Zagari RM, Hassan C, Fuccio L. 1L- vs. 4L-Polyethylene glycol for bowel preparation before colonoscopy among inpatients: A propensity score-matching analysis. Dig Liver Dis. 2020 Dec;52(12):1486-1493. doi: 10.1016/j.dld.2020.10.006. Epub 2020 Oct 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 4L-PEG | Drug | 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. |
|
Degree of serum potassium shift (mmol/L) before and after bowel preparation
| 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 | 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 | 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 | 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 | 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 | within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy |
| 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 CaritĂ | 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 |