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

Completed

• Conditions: Colonoscopy; Hospitalized Patients; Bowel Preparation
• Interventions: Drug: 4L-PEG; Drug: 1L-PEG

• Registration Number: NCT04310332
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4L-PEG	4L-PEG	Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation.
1L-PEG	1L-PEG	Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation.

Primary Outcome Measures

Name	Time	Method
Overall colon cleansing efficacy	Outcome will be assessed during colonoscopy	Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)
Right colon cleansing efficacy	Outcome is assessed during colonoscopy	Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)

Secondary Outcome Measures

Name	Time	Method
Safety (hematocrit change)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of change in hematocrit (%), before and after bowel preparation
Safety (serum creatinine imbalance)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of serum creatinine shift (mg/dL) before and after bowel preparation
Safety (glomerular filtration rate change)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of change in glomerular filtration rate (mL/min/1.73 m2), before and after bowel preparation
Safety (serum sodium imbalance)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of serum sodium shift (mmol/L) before and after bowel preparation
Safety (serum magnesium imbalance)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of serum magnesium shift (mg/dL) before and after bowel preparation
Safety (serum potassium imbalance)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of serum potassium shift (mmol/L) before and after bowel preparation
Safety (serum calcium imbalance)	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy	Degree of serum calcium shift (mg/dL) before and after bowel preparation

Trial Locations

Locations (10)

Policlinico Sant'Orsola-Malpighi; 🇮🇹 Bologna, Italy

Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna; 🇮🇹 Forlì, Italy

Digestive Endoscopy Unit, Fondazione Poliambulanza; 🇮🇹 Brescia, Italy

Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità; 🇮🇹 Novara, Italy

UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena; 🇮🇹 Carpi, Italy

Gastroenterology Unit, Valduce Hospital; 🇮🇹 Como, Italy

Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital; 🇮🇹 Milan, Italy

Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital; 🇮🇹 Iglesias, Italy

Gastroenterology Unit, S. Maria delle Croci Hospital; 🇮🇹 Ravenna, Italy

Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital; 🇮🇹 Piacenza, Italy