Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03298945




Registration number
NCT03298945
Ethics application status
Date submitted
26/09/2017
Date registered
2/10/2017
Date last updated
1/10/2024

Titles & IDs
Public title
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Scientific title
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Secondary ID [1] 0 0
IIR 15-346
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Miralax-Gatorade Prep
Treatment: Drugs - Golytely

Active comparator: Golytely - 4-L split-dose Golytely bowel prep

Experimental: Miralax-Gatorade prep - 2-L split-dose Miralax-Gatorade bowel prep


Treatment: Drugs: Miralax-Gatorade Prep
2-L split-dose Miralax-Gatorade bowel prep for colonoscopy

Treatment: Drugs: Golytely
4-L split dose Golytely is the current standard prep at the VA
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
colonoscopy completion rate
Timepoint [1] 0 0
This outcome is determined within 1 month after colonoscopy
Primary outcome [2] 0 0
Population level adenoma detection rate (ADR)
Timepoint [2] 0 0
within 1 month of colonoscopy
Secondary outcome [1] 0 0
cancellation or no-show in each bowel prep arm
Timepoint [1] 0 0
within 1 month after colonoscopy
Secondary outcome [2] 0 0
Adequate bowel prep quality
Timepoint [2] 0 0
within 1 month after the colonoscopy

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2024
Sample size
Target
Accrual to date
Final
2261
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Government body
Name
VA Office of Research and Development
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03298945
Trial related presentations / publications
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Yu-Xiao Yang, MD MSCE
Address 0 0
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03298945