Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04361656 |
| Other study ID # |
1474341 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
February 4, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Ascension South East Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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 increase the safety of therapeutic maneuvers. Prior studies revealed that
inpatient setting was associated with higher rate of poor bowel preparation which led to
lower rate of procedure completion. The addition of Lubiprostone to standard PEG-ELS bowel
preparation for colonoscopy was evaluated in the outpatient setting and revealed
significantly better colon cleansing, decrease total length of procedure, and improved the
overall patient satisfaction with the preparation.
The aim of this trial is to evaluate the effect of adding Lubiprostone to standard
large-volume PEG-ELS on the bowel preparation for inpatient colonoscopy.
2.2. Background Colonoscopy is a procedure that permits direct visualization, examination and
treatment of the rectum, colon and terminal ileum. It can be used for both diagnostic and
therapeutic purposes. In order to perform a high-quality colonoscopy examination, the
American Society of Gastrointestinal Endoscopy/American College of Gastroenterology Taskforce
on Quality in Endoscopy committee established a pre-, intra- and post-procedural quality
indicators. Bowel preparation is one of the most important pre-procedural indicators, as an
excellent preparation is crucial to visualize the entire colonic mucosa and to increase the
safety of therapeutic maneuvers. Multiple studies revealed rates of incomplete colonoscopy
between 10-20%, Sidhu et al revealed a rate of 7.8% of incomplete colonoscopies with
inadequate bowel preparation being the most common culprit. It has been reported that
inadequate or poor preparation occurs in 20-25% of colonoscopies in the United States. The
diagnostic yield, safety and quality indicators (adenoma detection rate, withdrawal time and
cecal intubation rate) of colonoscopy can be inversely affected by inadequate or poor bowel
preparation, as it can lead to: Increase procedural duration, cancel or repeat procedures,
increase health costs, a potential increase in complications and increase probability of
missing neoplastic lesions or adenomatous polyps (28-42% patients had adenomas on repeated
exam within 3 years).
Factors that can be associated with inadequate or poor bowel preparation has been evaluated
by researchers in order to improve this quality indicator. It has been shown that inadequate
preparation is more likely in the following situations: Inpatient status, prior inadequate
bowel preparation, advanced age, comorbidities (obesity, cirrhosis, stroke, dementia, and
Parkinson's), language barrier, polypharmacy, late colonoscopy starting time and failure to
follow preparation instructions. Ness et al and Almadi et al in their studies found that
inpatient setting was associated with higher rate of poor bowel preparation which led to
lower rate of procedure completion and terminal ileum intubation. An ideal bowel cleansing
preparation should be safe, tolerable, affordable, and can reliably empty the colon in a
timely fashion without altering the colonic mucosa histology. The large-volume polyethylene
glycol-electrolyte solution (PEG-ELS) is one of the most used FDA approved bowel preparation
methods. PEG-ELS is an inert polymer of ethylene oxide formulated as a non-absorbable
solution which is osmotically balanced with non-fermentable electrolyte solutions. It passes
through the gastrointestinal tract without net absorption, secretion, or significant effect
on fluid and electrolyte shift. Giving part of the bowel preparation does on the same day as
the colonoscopy (termed split-does) results in a higher quality colonoscopy examination
compared with ingestion of the entire preparation on the day or evening before colonoscopy.
As no available preparation has all of the ideal characteristics, studies evaluated the
effect of adding other medications to enhance the quality of the preparation. The routine
addition of prokinetic agents or bisacodyl to one of the standard regimens (Polyethylene
glycol-electrolyte solution) did not improve patient tolerance or colonic cleansing.
Lubiprostone is a derivative of prostaglandin E1 which has been shown to be effective in
treating Chronic Idiopathic Constipation, Opioid Induced Constipation and Irritable Bowel
Syndrome-Constipation (IBS-C). Lubiprostone works by stimulating and inducing the secretion
of chloride by activating chloride channel Type-2 and cyctic fibrosis transmembrane
conductance regulator chloride channels in the apical membrane of the intestinal epithelial
cells. Ultimately, the release of chloride ions from the cells into the intestinal lumen
results in increase fluidity within the lumen itself. Furthermore, the increase of fluid
contents within the lumen results in increase luminal distention which promotes the
gastrointestinal tract motility, resulting in an increase in intestinal and colonic transit.
By increasing the fluid content within the luminal wall and increasing intestinal and colonic
transit, the resultant benefit is softening of stool and rather rapid and facilitated
emptying of colonic contents which results in improvement in constipation and efficient
colonic emptying.
Joel et al, and Banerjee et al evaluated the addition of Lubiprostone to standard PEG-ELS
bowel preparation for colonoscopy performed in the outpatient setting. They showed
significantly better colon cleansing, decreased total length of procedure, and improved
overall patient satisfaction with the preparation. Grigg et al revealed a trend toward
improved quality of colonoscopy preparation by adding two doses of Lubiprostone to standard
PEG in diabetic patients undergoing outpatient screening colonoscopy. Documentation of
quality of bowel preparation is an important post-procedural quality indicator. The Boston
Bowel Preparation Scale is one of the most commonly used validated systems in the literature
for documentation of the colonoscopy preparation. It is a 10-point (0-9) summation score
assessing bowel preparation quality in 3 segments of the colon after all cleansing maneuvers
during colonoscopy.
2.3. Risk/Benefit assessment 2.3.1. Known potential risks Lubiprostone is an approved and
licensed medication. The Product/Safety Information published on the company website
(https://www.amitiza.com/hcp/safety-indication/chronic-idiopathic-constipation) was used as
the primary source of the potential risks associated with Lubiprostone use.
"Lubiprostone is not for everyone". It is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction. It should be avoided in patients with severe
diarrhea and during pregnancy (unless the potential benefit justifies the potential risk to
the fetus). Caution should be exercised when it is administered to a nursing woman. These
were included as exclusion criteria. Syncope, hypotension and dyspnea have been reported
within an hour of the first dose or subsequent doses of Lubiprostone and generally resolve
prior to the next dose, but may recur with repeat dosing. In clinical trials of Lubiprostone
(24 microgram (mcg) twice daily vs placebo), the most common adverse reactions (incidence >
4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8%
vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%). There was no clinically
significant changes in serum electrolyte levels in adult patients with CIC receiving
Lubiprostone.
Other potential risks associated with PEG-ELS and colonoscopy procedure are not included in
this study protocol as they are considered part of the standard of care required for patient
evaluation and not part of this research study.
2.3.2. Known potential benefits The addition of Lubiprostone to standard PEG-ELS bowel
preparation for colonoscopy was evaluated in the outpatient setting and revealed
significantly better colon cleansing, decrease total length of procedure, and improved the
overall patient satisfaction with the preparation. This would potentially result in reduce
health costs, decrease complications rate and enhance the accuracy of neoplastic lesions or
adenomatous polyp detection rates.
3 STUDY OBJECTIVES AND OUTCOMES 3.1 Objectives 3.1.1 Primary objective The primary objective
of this trial is to evaluate the effect of adding Lubiprostone to standard large-volume
PEG-ELS on the bowel preparation for inpatient colonoscopy.
3.1.2 Secondary objectives
The secondary objectives of this trial are:
1. To determine the adverse events related to the addition of Lubiprostone to large-volume
PEG-ELS.
2. To determine the overall patient satisfaction with the bowel preparation regimen with
the addition of Lubiprostone to large-volume PEG-ELS.
