Skip to main content
OpenTrials
Completed

NCT Number: NCT04310332

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonoscopy Bowel Preparation Hospitalized Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Sant'Orsola-Malpighi, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Overall colon cleansing efficacy

    Time frame: Outcome will be assessed during colonoscopy

    Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)

  2. Right colon cleansing efficacy

    Time frame: 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 outcomes

  1. Safety (serum sodium imbalance)

    Time frame: 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

  2. Safety (serum potassium imbalance)

    Time frame: 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

  3. Safety (serum calcium imbalance)

    Time frame: 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

  4. Safety (serum magnesium imbalance)

    Time frame: 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

  5. Safety (serum creatinine imbalance)

    Time frame: 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

  6. Safety (glomerular filtration rate change)

    Time frame: 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

  7. Safety (hematocrit change)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.