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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golytely | Active Comparator | 4-L split-dose Golytely bowel prep |
|
| Miralax-Gatorade prep | Experimental | 2-L split-dose Miralax-Gatorade bowel prep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miralax-Gatorade Prep | Drug | 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | within 1 month of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Cancellation or No-show in Each Bowel Prep Arm | The proportion of patients who cancel or no-show in each group. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 1 month after colonoscopy |
| Hyponatremia |
Inclusion Criteria:
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
Those with a preference for a specific bowel preparation will be excluded.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Xiao Yang, MD MSCE | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104-4551 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens: A Pragmatic Randomized Controlled Trial Yang, Yu-Xiao, Dawei Xie, Raphael Rivero, Michael W. Bond, Jibreel Damisa, Qiao Lu, Nabeel H. Khan Gastroenterology, 2024-05-18, Volume 166, Issue 5, Pages S-353-S-353 |
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Of the 3869 patients assessed for eligibility, 2239 met the eligibility criteria and were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Golytely | 4-L split-dose Golytely bowel prep Golytely: 4-L split dose Golytely is the current standard prep at the VA |
| FG001 | Miralax-Gatorade Prep | 2-L split-dose Miralax-Gatorade bowel prep Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Golytely | 4-L split-dose Golytely bowel prep Golytely: 4-L split dose Golytely is the current standard prep at the VA |
| BG001 | Miralax-Gatorade Prep | 2-L split-dose Miralax-Gatorade bowel prep Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | This outcome is determined within 1 month after colonoscopy |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Golytely | 4-L split-dose Golytely bowel prep Golytely: 4-L split dose Golytely is the current standard prep at the VA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colorectal cancer diagnosed on colonoscopy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yu-Xiao Yang, MD, MSCE | Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center | 215-823-5800 | yuxiao.yang@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2018 | Dec 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C033608 | Golytely |
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Parallel groups
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| Golytely | Drug | 4-L split dose Golytely is the current standard prep at the VA |
|
| within 1 month after the colonoscopy |
Hyponatremia |
| within 6 months after colonoscopy |
| Renal Failure | renal failure documented in CPRS | within 6 months of colonoscopy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index group | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Alcohol use disorder | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Constipation or narcotic use | Count of Participants | Participants |
|
| Mental health disorders | Count of Participants | Participants |
|
| Colonoscopy indications | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | within 1 month of colonoscopy |
|
|
|
| Secondary | Cancellation or No-show in Each Bowel Prep Arm | The proportion of patients who cancel or no-show in each group. | Posted | Count of Participants | Participants | within 1 month after colonoscopy |
|
|
|
| Secondary | Adequate Bowel Prep Quality | this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation | Not Posted | within 1 month after the colonoscopy | Participants |
| Other Pre-specified | 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 | Not Posted | within 1 month after colonoscopy | Participants |
| Other Pre-specified | Hyponatremia | Hyponatremia | Not Posted | within 6 months after colonoscopy | Participants |
| Other Pre-specified | Renal Failure | renal failure documented in CPRS | Not Posted | within 6 months of colonoscopy | Participants |
| 7 |
| 1,139 |
| 6 |
| 1,139 |
| 0 |
| 1,139 |
| EG001 | Miralax-Gatorade Prep | 2-L split-dose Miralax-Gatorade bowel prep Miralax-Gatorade Prep: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy | 4 | 1,100 | 5 | 1,100 | 0 | 1,100 |
| Hospitalization for mania and psychosis | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization for lung surgery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization for respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization for DKA | Endocrine disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |