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

Withdrawn before enrolling

Conditions studied: Colonoscopy Preparation

In brief

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).

Key facts

Study ID

NCT04361656

Run by

Henry Ford Health System

People needed

0

Starts

2020-05-01

Expected to finish

2021-02-04

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is scheduled for colonoscopy evaluation during his hospitalization to one of the trial sites (SJPH, PPH, or SJMH).
• Has a negative urine pregnancy test (hCG) for female of reproductive age.
• Provide an Informed Consent / has a legally acceptable representative capable of understanding the Informed Consent document and providing consent on the participant's behalf.
• Provide a separate signed and dated Informed Consents for colonoscopy procedure and anaesthesia administration as per site policy.

You may not qualify if…

• Has a documented or suspected bowel obstruction (small bowel obstruction, volvulus, gastric outlet obstruction, ileus, or toxic megacolon).
• Has a documented gastroparesis.
• Has severe diarrhea (>8 bowel movements per day).
• Has severe encephalopathy or obtunded (GCS < 13).
• Has a documented or suspected acute coronary syndrome or recent myocardial infarction within 12 weeks prior to enrollment.
• Has renal impairment with GFR less than 30 ml/min/1.73 m2 on the day of enrollment (end-stage renal disease on renal replacement therapy can be enrolled).
• Has severe liver impairment with Child-Pugh class B or C.
• Has symptomatic heart failure (NYHA class III or IV) or prohibitive pre-procedure cardiac risk (documented by primary team or cardiology prior to enrollment).
• Has a known hypersensitivity to Lubiprostone or its class.
• Is pregnant or lactating.

Where it is running

• Ascension Providence Hopsital (Novi) — Novi, Michigan, United States
• Ascension Providence Hospital, Southfield Campus — Southfield, Michigan, United States
• Ascension Macomb-Oakland Hospital — Warren, Michigan, United States

Full record on ClinicalTrials.gov

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