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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03298945
Other study ID # IIR 15-346
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date December 13, 2018
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2261
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Those with a preference for a specific bowel preparation 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Miralax-Gatorade Prep
2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
Golytely
4-L split dose Golytely is the current standard prep at the VA

Locations

Country Name City State
United States Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other hyponatremia Hyponatremia within 6 months after colonoscopy
Other renal failure renal failure documented in CPRS within 6 months of colonoscopy
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. This outcome is determined within 1 month after colonoscopy
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. 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. 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 within 1 month after the colonoscopy
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