Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens

NCT03298945 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IIR 15-346
• Study Type: interventional
• Target: 2,239
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colonoscopy; colorectal cancer; bowel preparation regimen; pragmatic trial

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Cancellation or No-show in Each Bowel Prep Arm

  within 1 month after colonoscopy

• Adequate Bowel Prep Quality

  within 1 month after the colonoscopy

Other Outcomes (3)

• Patients With Inadequate Bowel Preparation Who Are Recommended to Have Earlier-than-usual Follow-up Colonoscopy

  within 1 month after colonoscopy

• Hyponatremia

  within 6 months after colonoscopy

• Renal Failure

  within 6 months of colonoscopy

Study Arms (2)

Golytely

ACTIVE COMPARATOR

4-L split-dose Golytely bowel prep

Drug: Golytely

Miralax-Gatorade prep

EXPERIMENTAL

2-L split-dose Miralax-Gatorade bowel prep

Drug: Miralax-Gatorade Prep

Interventions

Miralax-Gatorade Prep DRUG

2-L split-dose Miralax-Gatorade bowel prep for colonoscopy

Miralax-Gatorade prep

Golytely DRUG

4-L split dose Golytely is the current standard prep at the VA

Golytely

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Golytely

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Yu-Xiao Yang, MD, MSCE
• Organization: Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center

yuxiao.yang@va.gov

215-823-5800

Study Officials

• Yu-Xiao Yang, MD MSCE

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel groups

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 2, 2017
• Study Start: December 13, 2018
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 5, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)