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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy, Hospitalized Patients, Bowel Preparation

Intervention / Treatment
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* Drug: 1L-PEG
* Drug: 4L-PEG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1L-PEG<br>Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation. | Drug: 1L-PEG<br>* 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.<br>|
| 4L-PEG<br>Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation. | Drug: 4L-PEG<br>* 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.<br>|

What is the study measuring?
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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 |