Prostate Cancer
Conditions
Keywords
Prostatectomy, Robotic, Urology
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.
Interventions
OTHERPneumoperitoneum Pressure 6 mmHg
A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
OTHERPneumoperitoneum Pressure 15 mmHg
A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
Sponsors
CONMED Corporation
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Medication Use | Through 1 week postoperatively | The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Scores | Through discharge (post-operative day 0 or post-operative day 1) | 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 | Intraoperatively | Average tidal volume (ml) |
| Discharge Day (Post-operative Day 0 or 1) | Through discharge (post-operative day 0 or 1) | The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant |
Countries
United States
Participant flow
Pre-assignment details
170 participants were consented/enrolled 31 participants were withdrawn prior to randomization (10 due to coronavirus-19 concerns; 9 due to principal investigator leaving the institution; 5 due to patient request; 3 due to change in eligibility; 3 due to resource availability; 1 at principal investigator request)
Participants by arm
| Arm | Count |
|---|---|
| Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg
Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP. | 68 |
| Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg
Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP. | 71 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Pressure 6 mmHg | Pressure 15 mmHg | Total |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 6.52 | 62.8 years STANDARD_DEVIATION 6.67 | 63.5 years STANDARD_DEVIATION 6.61 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 68 Participants | 71 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 68 | 0 / 71 |
| other Total, other adverse events | 0 / 68 | 0 / 71 |
| serious Total, serious adverse events | 1 / 68 | 0 / 71 |
Outcome results
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.
Time frame: Through 1 week postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pressure 6 mmHg | Postoperative Pain Medication Use | 56.6 morphine milligram equivalents | Standard Deviation 40.72 |
| Pressure 15 mmHg | Postoperative Pain Medication Use | 61.2 morphine milligram equivalents | Standard Deviation 37.33 |
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
Time frame: Through discharge (post-operative day 0 or 1)
Population: The post-operative discharge day was not recorded for one participant in each group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pressure 6 mmHg | Discharge Day (Post-operative Day 0 or 1) | Discharged on Post-operative day 0 | 56 Participants |
| Pressure 6 mmHg | Discharge Day (Post-operative Day 0 or 1) | Discharged on Post-operative day 1 | 11 Participants |
| Pressure 15 mmHg | Discharge Day (Post-operative Day 0 or 1) | Discharged on Post-operative day 0 | 62 Participants |
| Pressure 15 mmHg | Discharge Day (Post-operative Day 0 or 1) | Discharged on Post-operative day 1 | 8 Participants |
Secondary
Operative Ventilation
Average tidal volume (ml)
Time frame: Intraoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pressure 6 mmHg | Operative Ventilation | 629.1 milliliters | Standard Deviation 81.9 |
| Pressure 15 mmHg | Operative Ventilation | 629.4 milliliters | Standard Deviation 83.1 |
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.
Time frame: Through discharge (post-operative day 0 or post-operative day 1)
Population: Post-operative pain scores were not recorded for one participant in the Pneumoperitoneum pressure 6 mmHg group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pressure 6 mmHg | Post Operative Pain Scores | 1.4 Units on a scale | Standard Deviation 1.61 |
| Pressure 15 mmHg | Post Operative Pain Scores | 1.8 Units on a scale | Standard Deviation 1.86 |