Ultralow Versus Standard Pneumoperitoneum Pressure (Ultralow)
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pneumoperitoneum Pressure 6 mmHg
Pneumoperitoneum Pressure 15 mmHg
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomy, Robotic, Urology
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Diagnosed with prostate cancer
- Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Exclusion Criteria:
- 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
Sites / Locations
- Dublin Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pressure 6 mmHg
Pressure 15 mmHg
Arm Description
Pneumoperitoneum Pressure 6 mmHg
Pneumoperitoneum Pressure 15 mmHg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Operative Ventilation
Average tidal volume (ml)
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
Full Information
NCT ID
NCT03630393
First Posted
August 10, 2018
Last Updated
February 17, 2022
Sponsor
OhioHealth
Collaborators
CONMED Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03630393
Brief Title
Ultralow Versus Standard Pneumoperitoneum Pressure
Acronym
Ultralow
Official Title
Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
Collaborators
CONMED Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatectomy, Robotic, Urology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pressure 6 mmHg
Arm Type
Experimental
Arm Description
Pneumoperitoneum Pressure 6 mmHg
Arm Title
Pressure 15 mmHg
Arm Type
Active Comparator
Arm Description
Pneumoperitoneum Pressure 15 mmHg
Intervention Type
Other
Intervention Name(s)
Pneumoperitoneum Pressure 6 mmHg
Intervention Description
A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
Intervention Type
Other
Intervention Name(s)
Pneumoperitoneum Pressure 15 mmHg
Intervention Description
A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
Primary Outcome Measure Information:
Title
Postoperative Pain Medication Use
Description
The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.
Time Frame
Through 1 week postoperatively
Secondary Outcome Measure Information:
Title
Post Operative Pain Scores
Description
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.
Time Frame
Through discharge (post-operative day 0 or post-operative day 1)
Title
Operative Ventilation
Description
Average tidal volume (ml)
Time Frame
Intraoperatively
Title
Discharge Day (Post-operative Day 0 or 1)
Description
The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant
Time Frame
Through discharge (post-operative day 0 or 1)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males with prostate cancer who are eligible and electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Diagnosed with prostate cancer
Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronney Abaza, MD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dublin Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultralow Versus Standard Pneumoperitoneum Pressure
We'll reach out to this number within 24 hrs