A Phase 4 interventional study of Miralax-Gatorade Prep and Golytely in Colorectal Cancer, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Health services research
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.
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).
Exclusion Criteria:
Those with a preference for a specific bowel preparation will be excluded.
4-L split-dose Golytely bowel prep
Drug: Golytely
2-L split-dose Miralax-Gatorade bowel prep
Drug: Miralax-Gatorade Prep
2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
4-L split dose Golytely is the current standard prep at the VA
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.
Time frame: This outcome is determined within 1 month after 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.
Time frame: within 1 month of colonoscopy
Cancellation or No-show in Each Bowel Prep Arm
The proportion of patients who cancel or no-show in each group.
Time frame: within 1 month after colonoscopy
Adequate Bowel Prep Quality
this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation
Time frame: within 1 month after the colonoscopy
Patients With Inadequate Bowel Preparation Who Are Recommended to Have Earlier-than-usual Follow-up Colonoscopy
patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
Time frame: within 1 month after colonoscopy
Hyponatremia
Hyponatremia
Time frame: within 6 months after colonoscopy
Renal Failure
renal failure documented in CPRS
Time frame: within 6 months of colonoscopy
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.
| Milestone | Golytely | Miralax-Gatorade Prep |
|---|---|---|
| Started | 1139 | 1100 |
| Completed | 1139 | 1100 |
| Not completed | 0 | 0 |
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.
| Participants | Golytely | Miralax-Gatorade Prep |
|---|---|---|
| Colonoscopy Completion Rate | 591 | 600 |
the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.
| Participants | Golytely | Miralax-Gatorade Prep |
|---|---|---|
| Population Level Adenoma Detection Rate (ADR) | 383 | 364 |
The proportion of patients who cancel or no-show in each group.
| Participants | Golytely | Miralax-Gatorade Prep |
|---|---|---|
| Cancellation or No-show in Each Bowel Prep Arm | 358 | 330 |
this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation
Results for this outcome have not been posted.
patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
Results for this outcome have not been posted.
Hyponatremia
Results for this outcome have not been posted.
renal failure documented in CPRS
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Golytely | 7/1,139 (0.6%) | 6/1,139 (0.5%) | 0/1,139 (0%) |
| Miralax-Gatorade Prep | 4/1,100 (0.4%) | 5/1,100 (0.5%) | 0/1,100 (0%) |
| Event | Golytely | Miralax-Gatorade Prep |
|---|---|---|
| Colorectal cancer diagnosed on colonoscopyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1139 | 5/1100 |
| Hospitalization for mania and psychosisPsychiatric disorders | 1/1139 | 0/1100 |
| Hospitalization for lung surgeryRespiratory, thoracic and mediastinal disorders | 1/1139 | 0/1100 |
| Hospitalization for respiratory distressRespiratory, thoracic and mediastinal disorders | 1/1139 | 0/1100 |
| Hospitalization for DKAEndocrine disorders | 1/1139 | 0/1100 |
| Age, Continuous(years) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| Mean | 62.6 ± 9.7 | 62.6 ± 9.5 | 62.6 ± 7.2 |
| Sex: Female, Male(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| Female | 107 | 113 | 220 |
| Male | 1032 | 987 | 2019 |
| Ethnicity (NIH/OMB)(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| Hispanic or Latino | 36 | 48 | 84 |
| Not Hispanic or Latino | 1074 | 1020 | 2094 |
| Unknown or Not Reported | 29 | 32 | 61 |
| Race (NIH/OMB)(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 18 | 28 |
| Native Hawaiian or Other Pacific Islander | 9 | 18 | 27 |
| Black or African American | 407 | 397 | 804 |
| White | 670 | 631 | 1301 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 43 | 36 | 79 |
| Body mass index group(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| <18.5 kg/m^2 | 10 | 9 | 19 |
| 18.5 to 24.9 kg/m^2 | 198 | 175 | 373 |
| 25 to 29.9 kg/m^2 | 395 | 368 | 763 |
| 30 or more kg/m^2 | 527 | 543 | 1070 |
| Missing | 9 | 5 | 14 |
| Smoking status(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| Never smoker | 347 | 339 | 686 |
| Former smoker | 455 | 430 | 885 |
| Current smoker | 327 | 306 | 633 |
| Missing | 10 | 25 | 35 |
| Alcohol use disorder(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| Count of participants | 108 | 116 | 224 |
| Diabetes mellitus(Participants) | Golytely | Miralax-Gatorade Prep | Total |
|---|---|---|---|
| Count of participants | 334 | 329 | 663 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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