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The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation

NCT04361656 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-12-19

No results posted yet for this study

Summary

This is a multicenter interrupted-time series study. The study will include patients between the age of 18-85 year old, both males and females, who are scheduled for inpatient colonoscopy procedure.

The study will be divided into two phases:

The initial phase will be a prospective review of inpatient colonoscopy procedure between September, 1st 2020 and March, 31st 2021 to assess overall adequacy of inpatient colonoscopy preparation and patient satisfaction at the three participating sites using standard of care colonoscopy preparation prior to implement our intervention.

The intervention phase will take place between April, 1st 2021 and October 31st 2021, where all patient undergoing inpatient colonoscopy procedures will receive Lubiprostone in addition to large-volume PEG-ELS.

The patients will be evaluated with colonoscopy the next day. The preparation quality will be documented using the Boston Bowel Preparation Scale (BBPS).

Conditions

  • Colonoscopy Preparation

Interventions

DRUG

PEG-ELS current standard of care

Standard of care for inpatient colonoscopy

DRUG

PEG-ELS current standard of care plus Lubiprostone 24 microgram Oral Cap (x2)

The dose of Lubiprostone will be 24 mcg capsule orally (roughly every 12 hours) for total of 2 doses, with the last dose being at least 4 hours prior to the scheduled colonoscopy if it is BEFORE 11 a.m., and Lubiprostone 24 mcg capsule orally 2 hours before each dose of the PEG-ELS if colonoscopy is scheduled AT or AFTER 11 a.m..

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Ali Zakaria, MD · Henry Ford Health System

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-02-04
Completion
2021-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361656 on ClinicalTrials.gov