The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality
- Conditions
- GLP - 1Bowel 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
- 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
-
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:
- Cirrhosis
- Parkinson's disease
- Dementia
- Tricyclic antidepressant use
- Opioid use
- 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)
- Previous colorectal surgery
- Prior history of inadequate bowel preparation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continue GLP/GIP medication Continue GLP/GIP Patient maintains dose, frequency, duration of medication prior to colonoscopy.
- Primary Outcome Measures
Name Time Method Rate of inadequate bowel preparation Day of the procedure
- Secondary Outcome Measures
Name Time Method Adenoma detection rate Day of procedure Median Boston bowel prep score Day of the procedure Colonoscope Insertion time Day of the Procedure Time it takes to reach the cecum
Total procedure time Day of the procedure Rate of unplanned endotracheal intubation Day of the procedure Median Ottawa bowel preparation score Day of the procedure Withdrawal time Day of the procedure 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.
Trial Locations
- Locations (2)
Cleveland Clinic
🇺🇸Cleveland, Florida, United States
Cleveland Clinic Weston
🇺🇸Weston, Florida, United States
Cleveland Clinic🇺🇸Cleveland, Florida, United StatesSamita Garg, M.D.Principal Investigator