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Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens

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ClinicalTrials.gov Identifier: NCT03298945
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Miralax-Gatorade Prep Drug: Golytely Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel groups
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : December 21, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: GoLytely

Arm Intervention/treatment
Active Comparator: Golytely
4-L split-dose Golytely bowel prep
Drug: Golytely
4-L split dose Golytely is the current standard prep at the VA

Experimental: Miralax-Gatorade prep
2-L split-dose Miralax-Gatorade bowel prep
Drug: Miralax-Gatorade Prep
2-L split-dose Miralax-Gatorade bowel prep for colonoscopy




Primary Outcome Measures :
  1. colonoscopy completion rate [ Time Frame: This outcome is determined within 1 month after colonoscopy ]
    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.

  2. Population level adenoma detection rate (ADR) [ Time Frame: within 1 month of colonoscopy ]
    the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.


Secondary Outcome Measures :
  1. cancellation or no-show in each bowel prep arm [ Time Frame: within 1 month after colonoscopy ]
    The proportion of patients who cancel or no-show in each group.

  2. Adequate bowel prep quality [ Time Frame: within 1 month after the colonoscopy ]
    this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation


Other Outcome Measures:
  1. patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy [ Time Frame: within 1 month after colonoscopy ]
    patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy

  2. hyponatremia [ Time Frame: within 6 months after colonoscopy ]
    Hyponatremia

  3. renal failure [ Time Frame: within 6 months of colonoscopy ]
    renal failure documented in CPRS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298945


Contacts
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Contact: Yu-Xiao Yang, MD MSCE (215) 823-5800 YuXiao.Yang@va.gov

Locations
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United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Yu-Xiao Yang, MD MSCE    215-823-5800    YuXiao.Yang@va.gov   
Principal Investigator: Yu-Xiao Yang, MD MSCE         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Yu-Xiao Yang, MD MSCE Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03298945     History of Changes
Other Study ID Numbers: IIR 15-346
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
colonoscopy
colorectal cancer
bowel preparation regimen
pragmatic trial
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents