Clinical trial NCT04310332: 1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.
Official title: 1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Hospitalized Patients
Bowel Preparation
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients who are scheduled a colonoscopy as inpatients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall colon cleansing efficacy
timeFrame: Outcome will be assessed during colonoscopy
measure: Right colon cleansing efficacy
timeFrame: Outcome is assessed during colonoscopy
Secondary outcomes:
measure: Safety (serum sodium imbalance)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
measure: Safety (serum potassium imbalance)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
measure: Safety (serum calcium imbalance)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
measure: Safety (serum magnesium imbalance)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
measure: Safety (serum creatinine imbalance)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
measure: Safety (glomerular filtration rate change)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
measure: Safety (hematocrit change)
timeFrame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
city: Brescia
country: Italy
facility: Digestive Endoscopy Unit, Fondazione Poliambulanza
city: Carpi
country: Italy
facility: UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena
city: Como
country: Italy
facility: Gastroenterology Unit, Valduce Hospital
city: Forlì
country: Italy
facility: Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna
city: Iglesias
country: Italy
facility: Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital
city: Milan
country: Italy
facility: Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital
city: Novara
country: Italy
facility: Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità
city: Piacenza
country: Italy
facility: Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital
city: Ravenna
country: Italy
facility: Gastroenterology Unit, S. Maria delle Croci Hospital
Study officials:
References:
citation: 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.