Bowel Preparation for Colonoscopy, GLP - 1
Conditions
Keywords
GLP-1, Bowel preparation for colonoscopy
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?
Interventions
DRUGContinue GLP/GIP
Continue GLP-1 or GIP-based therapy as prescribed prior to the procedure.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of inadequate bowel preparation | During Surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Ottawa bowel preparation score | During Surgery | — |
| Adenoma detection rate | During Surgery | — |
| Colonoscope Insertion time | During Surgery | Time it takes to reach the cecum |
| Withdrawal time | During Surgery | — |
| Median Boston bowel prep score | During Surgery | — |
| Rate of unplanned endotracheal intubation | During Surgery | — |
| hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedure | From the day of the procedure to 96 hours after the procedure | — |
| Other serious adverse events | Day of the procedure up to 96 hours after the procedure. | — |
| Total procedure time | During Surgery | — |
Countries
United States
Outcome results
None listed