Trial Outcomes & Findings for Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens (NCT NCT03298945)
NCT ID: NCT03298945
Last Updated: 2025-02-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2239 participants
Primary outcome timeframe
This outcome is determined within 1 month after colonoscopy
Results posted on
2025-02-05
Participant Flow
Participants were recruited based on referral from the primary care providers ordering colonoscopy at the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center. The first participant was enrolled on December 13, 2018, and the last participant was enrolled on January 27, 2023.
Of the 3869 patients assessed for eligibility, 2239 met the eligibility criteria and were randomized.
Participant milestones
| Measure |
Golytely
4-L split-dose Golytely bowel prep
Golytely: 4-L split dose Golytely is the current standard prep at the VA
|
Miralax-Gatorade Prep
2-L split-dose Miralax-Gatorade bowel prep
Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
1139
|
1100
|
|
Overall Study
COMPLETED
|
1139
|
1100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Baseline characteristics by cohort
| Measure |
Golytely
n=1139 Participants
4-L split-dose Golytely bowel prep
Golytely: 4-L split dose Golytely is the current standard prep at the VA
|
Miralax-Gatorade Prep
n=1100 Participants
2-L split-dose Miralax-Gatorade bowel prep
Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
|
Total
n=2239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1032 Participants
n=5 Participants
|
987 Participants
n=7 Participants
|
2019 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1074 Participants
n=5 Participants
|
1020 Participants
n=7 Participants
|
2094 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
407 Participants
n=5 Participants
|
397 Participants
n=7 Participants
|
804 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
670 Participants
n=5 Participants
|
631 Participants
n=7 Participants
|
1301 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Body mass index group
<18.5 kg/m^2
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Body mass index group
18.5 to 24.9 kg/m^2
|
198 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
373 Participants
n=5 Participants
|
|
Body mass index group
25 to 29.9 kg/m^2
|
395 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
763 Participants
n=5 Participants
|
|
Body mass index group
30 or more kg/m^2
|
527 Participants
n=5 Participants
|
543 Participants
n=7 Participants
|
1070 Participants
n=5 Participants
|
|
Body mass index group
Missing
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Smoking status
Never smoker
|
347 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
686 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
455 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
885 Participants
n=5 Participants
|
|
Smoking status
Current smoker
|
327 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
633 Participants
n=5 Participants
|
|
Smoking status
Missing
|
10 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Alcohol use disorder
|
108 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Diabetes mellitus
|
334 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
663 Participants
n=5 Participants
|
|
Constipation or narcotic use
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Mental health disorders
|
371 Participants
n=5 Participants
|
398 Participants
n=7 Participants
|
769 Participants
n=5 Participants
|
|
Colonoscopy indications
Screening
|
481 Participants
n=5 Participants
|
508 Participants
n=7 Participants
|
989 Participants
n=5 Participants
|
|
Colonoscopy indications
Surveillance
|
487 Participants
n=5 Participants
|
440 Participants
n=7 Participants
|
927 Participants
n=5 Participants
|
|
Colonoscopy indications
Diagnostic
|
171 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This outcome is determined within 1 month after colonoscopyThe 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.
Outcome measures
| Measure |
Golytely
n=1139 Participants
4-L split-dose Golytely bowel prep
Golytely: 4-L split dose Golytely is the current standard prep at the VA
|
Miralax-Gatorade Prep
n=1100 Participants
2-L split-dose Miralax-Gatorade bowel prep
Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
|
|---|---|---|
|
Colonoscopy Completion Rate
|
591 Participants
|
600 Participants
|
PRIMARY outcome
Timeframe: within 1 month of colonoscopythe ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.
Outcome measures
| Measure |
Golytely
n=1139 Participants
4-L split-dose Golytely bowel prep
Golytely: 4-L split dose Golytely is the current standard prep at the VA
|
Miralax-Gatorade Prep
n=1100 Participants
2-L split-dose Miralax-Gatorade bowel prep
Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
|
|---|---|---|
|
Population Level Adenoma Detection Rate (ADR)
|
383 Participants
|
364 Participants
|
SECONDARY outcome
Timeframe: within 1 month after colonoscopyThe proportion of patients who cancel or no-show in each group.
Outcome measures
| Measure |
Golytely
n=1139 Participants
4-L split-dose Golytely bowel prep
Golytely: 4-L split dose Golytely is the current standard prep at the VA
|
Miralax-Gatorade Prep
n=1100 Participants
2-L split-dose Miralax-Gatorade bowel prep
Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
|
|---|---|---|
|
Cancellation or No-show in Each Bowel Prep Arm
|
358 Participants
|
330 Participants
|
SECONDARY outcome
Timeframe: within 1 month after the colonoscopythis is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: within 1 month after colonoscopypatients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: within 6 months after colonoscopyHyponatremia
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: within 6 months of colonoscopyrenal failure documented in CPRS
Outcome measures
Outcome data not reported
Adverse Events
Golytely
Serious events: 6 serious events
Other events: 0 other events
Deaths: 7 deaths
Miralax-Gatorade Prep
Serious events: 5 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Golytely
n=1139 participants at risk
4-L split-dose Golytely bowel prep
Golytely: 4-L split dose Golytely is the current standard prep at the VA
|
Miralax-Gatorade Prep
n=1100 participants at risk
2-L split-dose Miralax-Gatorade bowel prep
Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer diagnosed on colonoscopy
|
0.18%
2/1139 • Number of events 2 • 6 months
|
0.45%
5/1100 • Number of events 5 • 6 months
|
|
Psychiatric disorders
Hospitalization for mania and psychosis
|
0.09%
1/1139 • Number of events 1 • 6 months
|
0.00%
0/1100 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for lung surgery
|
0.09%
1/1139 • Number of events 1 • 6 months
|
0.00%
0/1100 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for respiratory distress
|
0.09%
1/1139 • Number of events 1 • 6 months
|
0.00%
0/1100 • 6 months
|
|
Endocrine disorders
Hospitalization for DKA
|
0.09%
1/1139 • Number of events 1 • 6 months
|
0.00%
0/1100 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Yu-Xiao Yang, MD, MSCE
Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center
Phone: 215-823-5800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place