Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Primary Purpose
Colorectal Cancer
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Miralax-Gatorade Prep
Golytely
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring colonoscopy, colorectal cancer, bowel preparation regimen, pragmatic trial
Eligibility Criteria
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.
Sites / Locations
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Golytely
Miralax-Gatorade prep
Arm Description
4-L split-dose Golytely bowel prep
2-L split-dose Miralax-Gatorade bowel prep
Outcomes
Primary Outcome Measures
colonoscopy completion rate
The completion rate of scheduled colonoscopy will be defined as the proportion of patients who show up for their scheduled colonoscopy and have endoscopist-rated "adequate" bowel preparation quality, among those scheduled for a colonoscopy.
Population level adenoma detection rate (ADR)
the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.
Secondary Outcome Measures
cancellation or no-show in each bowel prep arm
The proportion of patients who cancel or no-show in each group.
Adequate bowel prep quality
this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation
Full Information
NCT ID
NCT03298945
First Posted
September 26, 2017
Last Updated
August 28, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03298945
Brief Title
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Official Title
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colonoscopy, colorectal cancer, bowel preparation regimen, pragmatic trial
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Golytely
Arm Type
Active Comparator
Arm Description
4-L split-dose Golytely bowel prep
Arm Title
Miralax-Gatorade prep
Arm Type
Experimental
Arm Description
2-L split-dose Miralax-Gatorade bowel prep
Intervention Type
Drug
Intervention Name(s)
Miralax-Gatorade Prep
Intervention Description
2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
Intervention Type
Drug
Intervention Name(s)
Golytely
Intervention Description
4-L split dose Golytely is the current standard prep at the VA
Primary Outcome Measure Information:
Title
colonoscopy completion rate
Description
The completion rate of scheduled colonoscopy will be defined as the proportion of patients who show up for their scheduled colonoscopy and have endoscopist-rated "adequate" bowel preparation quality, among those scheduled for a colonoscopy.
Time Frame
This outcome is determined within 1 month after colonoscopy
Title
Population level adenoma detection rate (ADR)
Description
the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.
Time Frame
within 1 month of colonoscopy
Secondary Outcome Measure Information:
Title
cancellation or no-show in each bowel prep arm
Description
The proportion of patients who cancel or no-show in each group.
Time Frame
within 1 month after colonoscopy
Title
Adequate bowel prep quality
Description
this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation
Time Frame
within 1 month after the colonoscopy
Other Pre-specified Outcome Measures:
Title
patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
Description
patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
Time Frame
within 1 month after colonoscopy
Title
hyponatremia
Description
Hyponatremia
Time Frame
within 6 months after colonoscopy
Title
renal failure
Description
renal failure documented in CPRS
Time Frame
within 6 months of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Xiao Yang, MD MSCE
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4551
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31560755
Citation
Patel D, Yang YX, Trivedi C, Kavani H, Xie D, Medvedeva E, Lewis J, Khan N. Incidence, Duration, and Management of Anemia: A Nationwide Comparison Between IBD and Non-IBD Populations. Inflamm Bowel Dis. 2020 May 12;26(6):934-940. doi: 10.1093/ibd/izz206.
Results Reference
result
Learn more about this trial
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
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