Ultralow Versus Standard Pneumoperitoneum Pressure (Ultralow)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Pneumoperitoneum Pressure 6 mmHg; Other: Pneumoperitoneum Pressure 15 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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43016
      • Dublin Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pressure 6 mmHg; Pneumoperitoneum Pressure 6 mmHg	Other: Pneumoperitoneum Pressure 6 mmHg; A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
Active Comparator: Pressure 15 mmHg; Pneumoperitoneum Pressure 15 mmHg	Other: Pneumoperitoneum Pressure 15 mmHg; A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Medication Use	The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.	Through 1 week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain Scores	Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.	Through discharge (post-operative day 0 or post-operative day 1)
Operative Ventilation	Average tidal volume (ml)	Intraoperatively
Discharge Day (Post-operative Day 0 or 1)	The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant	Through discharge (post-operative day 0 or 1)

Collaborators and Investigators

• Sponsor: OhioHealth
• Collaborators: CONMED Corporation
• Investigators: Principal Investigator: Ronney Abaza, MD, OhioHealth

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Robotic; Prostatectomy; Urology
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 1306218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No