Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures
Completed
Conditions studied: Acute Pain, Surgery
In brief
The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as compared to a group of subjects with the same attributes without the guidance of PGx testing (historical control group). This study will also evaluate the frequency with which the standard analgesic care plan is adjusted by test results.
Key facts
- Study ID
- NCT02605343
- Run by
- AltheaDx
- People needed
- 110
- Starts
- 2015-08-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects over the age of 18
- Presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
- Willing and able to comply with study procedures
- Able to provide written informed consent
You may not qualify if…
- Unwilling or unable to provide written informed consent and to comply with study procedures;
- Unwilling or unable to provide buccal swab sample
- History of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5);
- New York Heart Classification >3
- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis);
- History of malabsorption (short gut syndrome);
- Gastric or small bowel surgery less than 3 months prior to study enrollment;
Where it is running
- University Hospitals of Cleveland Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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