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

NCT04310332 | Completed FDA Drug

• 1 other identifier: QIPS propensity score matching
• Study Type: observational
• Target: 1,004
• Locations: 1 country
• Sites: 10

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.

Conditions

Colonoscopy; Hospitalized Patients; Bowel Preparation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Safety (serum sodium imbalance)

  within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy

• Safety (serum potassium imbalance)

  within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy

• Safety (serum calcium imbalance)

  within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy

• Safety (serum magnesium imbalance)

  within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy

• Safety (serum creatinine imbalance)

  within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy

Study Arms (2)

1L-PEG

Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation.

Drug: 1L-PEG

4L-PEG

Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation.

Drug: 4L-PEG

Interventions

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.

1L-PEG

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.

4L-PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients who are scheduled a colonoscopy as inpatients.

You may qualify if:

• Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (10)

Policlinico Sant'Orsola-Malpighi

Bologna, Italy

Location

Digestive Endoscopy Unit, Fondazione Poliambulanza

Brescia, Italy

Location

UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena

Carpi, Italy

Location

Gastroenterology Unit, Valduce Hospital

Como, Italy

Location

Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna

Forlì, Italy

Location

Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital

Iglesias, Italy

Location

Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital

Milan, Italy

Location

Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità

Novara, Italy

Location

Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital

Piacenza, Italy

Location

Gastroenterology Unit, S. Maria delle Croci Hospital

Ravenna, Italy

Location

Related Publications (1)

• 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.

  PMID: 33250131 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: February 1, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)