The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Co… (NCT04361656) | Clinical Trial Compass
WithdrawnNot Applicable
The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation
Stopped: Endoscopy services were suspended in March 2019 due to COVID-19 pandemic. Study was not restarted.
United States0Started 2020-05-01
Plain-language 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).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Independent gastroenterologists BBPS review
Timeframe: scored at completion of all data collection,or after 2023
2
Participant satisfaction through standardized questionnaire form