1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.

1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.

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 Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation; Hospitalized Patients
• Intervention / Treatment: Drug: 1L-PEG; Drug: 4L-PEG

• Study Type: Observational
• Enrollment (Actual): 1004

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Policlinico Sant'Orsola-Malpighi
  • Brescia, Italy
    • Digestive Endoscopy Unit, Fondazione Poliambulanza
  • Carpi, Italy
    • UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena
  • Como, Italy
    • Gastroenterology Unit, Valduce Hospital
  • Forlì, Italy
    • Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna
  • Iglesias, Italy
    • Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital
  • Milan, Italy
    • Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital
  • Novara, Italy
    • Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità
  • Piacenza, Italy
    • Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital
  • Ravenna, Italy
    • Gastroenterology Unit, S. Maria delle Croci Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized patients who are scheduled a colonoscopy as inpatients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1L-PEG; Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation.	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; Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (ACTUAL): March 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: QIPS propensity score matching

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No