Ultralow Versus Standard Pneumoperitoneum Pressure

OhioHealth

Status: Terminated

Conditions: Prostate Cancer

Treatments: Other: Pneumoperitoneum Pressure 6 mmHg; Other: Pneumoperitoneum Pressure 15 mmHg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03630393

1306218

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 170 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Pressure 6 mmHg

Experimental group

Description:

Pneumoperitoneum Pressure 6 mmHg

Treatment:

Other: Pneumoperitoneum Pressure 6 mmHg

Pressure 15 mmHg

Active Comparator group

Description:

Pneumoperitoneum Pressure 15 mmHg

Treatment:

Other: Pneumoperitoneum Pressure 15 mmHg