Clinical trial NCT03630393: Ultralow Versus Standard Pneumoperitoneum Pressure
Official title: Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostatectomy
Robotic
Urology
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: CONMED Corporation
First posted: 2018-08-14
Enrollment: 170
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain Medication Use
timeFrame: Through 1 week postoperatively
Secondary outcomes:
measure: Post Operative Pain Scores
timeFrame: Through discharge (post-operative day 0 or post-operative day 1)
measure: Operative Ventilation
timeFrame: Intraoperatively
measure: Discharge Day (Post-operative Day 0 or 1)
timeFrame: Through discharge (post-operative day 0 or 1)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Dublin Methodist Hospital
state: Ohio
Study officials:
affiliation: OhioHealth
name: Ronney Abaza, MD
role: PRINCIPAL_INVESTIGATOR
References: