Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | December 13, 2018 |
| End Date: | September 30, 2021 |
| Contact: | Yu-Xiao Yang, MD MSCE |
| Email: | YuXiao.Yang@va.gov |
| Phone: | (215) 823-5800 |
From the patients' perspective, the most formidable part of the colonoscopy experience is the
process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to
incompletion of scheduled colonoscopies which in turn undermines the effectiveness of
colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel
preparation in the VA is of larger volume and less palatable than another commonly used bowel
preparation regimen. The investigators propose to compare these two commonly used bowel
preparations with respect to the overall completion rate of scheduled colonoscopies in a
real-world VA practice setting. The results of the study can be immediately applied to
maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.
process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to
incompletion of scheduled colonoscopies which in turn undermines the effectiveness of
colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel
preparation in the VA is of larger volume and less palatable than another commonly used bowel
preparation regimen. The investigators propose to compare these two commonly used bowel
preparations with respect to the overall completion rate of scheduled colonoscopies in a
real-world VA practice setting. The results of the study can be immediately applied to
maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.
Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation
regimen which is the most effective in real-world VA practice and can be immediately
implemented on a VA-wide scale, the proposed study will maximize the effectiveness of
colonoscopy in reducing colorectal cancer (CRC) risk among Veterans, increase Veteran
satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of
cancer-related death among Veterans. Colonoscopy can effectively reduce CRC incidence and
mortality. However, non-adherence to screening colonoscopy substantially undermines this
benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading
barrier to completing a colonoscopy from the patients' perspective. The taste and the volume
of the bowel preparation determine patient tolerability and compliance to the preparation
instructions, which in turn affects the incompletion (e.g., cancellation/no-show/reschedule)
rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies
and patient satisfaction. The two most commonly used preparations currently in the US are the
split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations.
While a high-volume regimen may in theory be more effective than a lower volume one, it may
be associated with lower tolerability and adherence in real-world practice. Three small
trials have compared these two preparations. However, data from these explanatory trials
cannot inform policy decisions because they were conducted under artificial conditions,
restricted among narrow patient populations, and most importantly not designed to capture the
full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To
address this critical knowledge gap, the investigators are proposing a pragmatic trial to
determine the optimal split-dose bowel preparation in the general Veteran population.
Objectives: to compare the real-world effectiveness of the two most commonly used split-dose
colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with
respect to the completion rate of scheduled colonoscopies, adenoma detection rate and
secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes
(e.g., willingness to repeat the preparation).
regimen which is the most effective in real-world VA practice and can be immediately
implemented on a VA-wide scale, the proposed study will maximize the effectiveness of
colonoscopy in reducing colorectal cancer (CRC) risk among Veterans, increase Veteran
satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of
cancer-related death among Veterans. Colonoscopy can effectively reduce CRC incidence and
mortality. However, non-adherence to screening colonoscopy substantially undermines this
benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading
barrier to completing a colonoscopy from the patients' perspective. The taste and the volume
of the bowel preparation determine patient tolerability and compliance to the preparation
instructions, which in turn affects the incompletion (e.g., cancellation/no-show/reschedule)
rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies
and patient satisfaction. The two most commonly used preparations currently in the US are the
split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations.
While a high-volume regimen may in theory be more effective than a lower volume one, it may
be associated with lower tolerability and adherence in real-world practice. Three small
trials have compared these two preparations. However, data from these explanatory trials
cannot inform policy decisions because they were conducted under artificial conditions,
restricted among narrow patient populations, and most importantly not designed to capture the
full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To
address this critical knowledge gap, the investigators are proposing a pragmatic trial to
determine the optimal split-dose bowel preparation in the general Veteran population.
Objectives: to compare the real-world effectiveness of the two most commonly used split-dose
colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with
respect to the completion rate of scheduled colonoscopies, adenoma detection rate and
secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes
(e.g., willingness to repeat the preparation).
Inclusion Criteria:
- > 18 years of age, and
- being scheduled for outpatient elective screening, surveillance or diagnostic
colonoscopies, and
- the provider ordering the colonoscopy giving permission to enroll the patient.
Exclusion Criteria:
- Patients who are <18 years
- undergoing inpatient colonoscopy
- those with contra-indications to receiving the standard 4L PEG-ELS colonoscopy bowel
preparation (e.g., allergy to PEG) will be excluded
- The investigators are excluding inpatient colonoscopies because they account for
a very small fraction of the total colonoscopies performed.
- Also, inpatient colonoscopies are often performed for urgent reasons such that
rapid bowel preparation procedures are followed.
- In addition, because the objective of inpatient colonoscopy is often not to look for
small polyps, the threshold for "adequate" bowel preparation quality might be
different from that for outpatient procedures.
- In addition, for patients undergoing more than 1 colonoscopy during the study period,
only their first colonoscopy will be included in the primary analysis.
- Patients who are undergoing a repeat colonoscopy for to a recent inadequate
colonoscopy examination with poor bowel preparation will be excluded.
We found this trial at
1
site
3900 Woodland Avenue
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Principal Investigator: Yu-Xiao Yang, MD MSCE
Phone: 215-823-5800
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