Ultralow Versus Standard Pneumoperitoneum Pressure
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/21/2019 |
| Start Date: | April 2019 |
| End Date: | March 2021 |
| Contact: | Deborah Chervin |
| Email: | deborah.chervin@ohiohealth.com |
| Phone: | 614-544-8430 |
Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
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.
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.
The investigators to examine the impact of low pressure during robotic assisted laparoscopic
prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit
participants. The investigators hypothesize that a low insufflation pressure may provide an
improvement in postoperative pain and abdominal distension in addition to potential
physiologic benefits, and that these factors might then allow a shorter hospital stay. The
investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform
RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as
needed on an individual participant level. In order to determine whether this might allow
earlier discharge when successful, the investigators began allowing for same-day discharge in
participants meeting appropriate criteria. Having now demonstrated feasibility in over 300
consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now
plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having
RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.
prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit
participants. The investigators hypothesize that a low insufflation pressure may provide an
improvement in postoperative pain and abdominal distension in addition to potential
physiologic benefits, and that these factors might then allow a shorter hospital stay. The
investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform
RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as
needed on an individual participant level. In order to determine whether this might allow
earlier discharge when successful, the investigators began allowing for same-day discharge in
participants meeting appropriate criteria. Having now demonstrated feasibility in over 300
consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now
plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having
RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.
Inclusion Criteria:
1. Age 18 or older
2. Diagnosed with prostate cancer
3. Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Exclusion Criteria:
1. Age < 18
2. Emergency surgery
3. Patients with a significant preoperative dependence on narcotic medications
4. Unable to give informed consent
5. Dementia, history of dementia, or other significant mental impairment that would, in
the opinion of the investigator, impede patient self-reporting
6. 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)
7. Non-English-speaking or reading
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