Status:
WITHDRAWN
The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation
Lead Sponsor:
Henry Ford Health System
Conditions:
Colonoscopy Preparation
Eligibility:
All Genders
18-85 years
Brief 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. ...
Detailed Description
2\. INTRODUCTION AND BACKGROUND 2.1. Study rationale and aim An excellent bowel preparation is crucial to perform a high-quality colonoscopy and essential to visualize the entire colonic mucosa and to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04361656
Start Date
May 1 2020
End Date
February 4 2021
Last Update
December 19 2025
Active Locations (3)
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1
Ascension Providence Hopsital (Novi)
Novi, Michigan, United States, 48374
2
Ascension Providence Hospital, Southfield Campus
Southfield, Michigan, United States, 48075
3
Ascension Macomb-Oakland Hospital
Warren, Michigan, United States, 48093