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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04310332
Other study ID # QIPS propensity score matching
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date December 15, 2019

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
1L-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.
4L-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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

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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