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The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality

Not Applicable
Recruiting
Conditions
GLP - 1
Bowel Preparation for Colonoscopy
Interventions
Drug: Continue GLP/GIP
Registration Number
NCT07127354
Lead Sponsor
The Cleveland Clinic
Brief Summary

The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are:

* Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation?

* Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication?

* Are there any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Adult patient (Age 18 years or older)
  • Patient scheduled for outpatient screening, surveillance, or diagnostic colonoscopy
  • Using a GLP-1 or GIP agonist at a stable dose for at least one month
Exclusion Criteria
  • Unable to provide informed consent, e.g., dementia

  • Patient refuses the USMSTF recommended bowel cleansing regimen for patients with diabetes or obesity (split-dose 4 liters polyethylene glycol + 15 mg bisacodyl the afternoon before; low residue diet 3 days before colonoscopy; clear liquid diet the day before colonoscopy)

  • Risk factors for inadequate bowel preparation besides diabetes and obesity with a likelihood ratio of 1.6 or greater:

    1. Cirrhosis
    2. Parkinson's disease
    3. Dementia
    4. Tricyclic antidepressant use
    5. Opioid use
    6. Gastroparesis* or suspected gastric outlet obstruction on pre-procedure imaging (*defined based on a documented 4-hour solid phase gastric emptying study or prior history of retained gastric contents during upper endoscopy)
    7. Previous colorectal surgery
    8. Prior history of inadequate bowel preparation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Continue GLP/GIP medicationContinue GLP/GIPPatient maintains dose, frequency, duration of medication prior to colonoscopy.
Primary Outcome Measures
NameTimeMethod
Rate of inadequate bowel preparationDay of the procedure
Secondary Outcome Measures
NameTimeMethod
Adenoma detection rateDay of procedure
Median Boston bowel prep scoreDay of the procedure
Colonoscope Insertion timeDay of the Procedure

Time it takes to reach the cecum

Total procedure timeDay of the procedure
Rate of unplanned endotracheal intubationDay of the procedure
Median Ottawa bowel preparation scoreDay of the procedure
Withdrawal timeDay of the procedure
hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedureFrom the day of the procedure to 96 hours after the procedure
Other serious adverse eventsDay of the procedure up to 96 hours after the procedure.

Trial Locations

Locations (2)

Cleveland Clinic

🇺🇸

Cleveland, Florida, United States

Cleveland Clinic Weston

🇺🇸

Weston, Florida, United States

Cleveland Clinic
🇺🇸Cleveland, Florida, United States
Samita Garg, M.D.
Principal Investigator

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