Colonoscopy Clinical Trial
Official title:
1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.
Verified date | March 2020 |
Source | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1004 |
Est. completion date | December 15, 2019 |
Est. primary completion date | December 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | 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 |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Safety (serum potassium imbalance) | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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