Ultralow Versus Standard Pneumoperitoneum Pressure

Prostate Cancer Clinical Trial

— Ultralow  

Official title:

Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03630393
• Other study ID #: 1306218
• Status: Terminated
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: February 10, 2021

Study information

• Verified date: February 2022
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumoperitoneum
• Prostate Cancer

Intervention

Other:
• Pneumoperitoneum Pressure 6 mmHg
A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
• Pneumoperitoneum Pressure 15 mmHg
A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Locations

Country	Name	City	State
United States	Dublin Methodist Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	ConMed Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Operative Ventilation	Average tidal volume (ml)	Intraoperatively
Secondary	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)