Ultralow Versus Standard Pneumoperitoneum Pressure
Stopped early · Not applicable
Conditions studied: Prostate Cancer
In brief
The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.
Key facts
- Study ID
- NCT03630393
- Run by
- OhioHealth
- People needed
- 170
- Starts
- 2019-05-09
- Expected to finish
- 2021-02-10
- Last updated by the study team
- 2022-02-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 or older
- Diagnosed with prostate cancer
- Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
You may not qualify if…
- Age < 18
- Emergency surgery
- Patients with a significant preoperative dependence on narcotic medications
- Unable to give informed consent
- Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
- Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)
- Non-English-speaking or reading
Where it is running
- Dublin Methodist Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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