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PI left institution
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| Name | Class |
|---|---|
| CONMED Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure 6 mmHg | Experimental | Pneumoperitoneum Pressure 6 mmHg |
|
| Pressure 15 mmHg | Active Comparator | Pneumoperitoneum Pressure 15 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumoperitoneum Pressure 6 mmHg | Other | A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP). |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Males with prostate cancer who are eligible and electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
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| Name | Affiliation | Role |
|---|---|---|
| Ronney Abaza, MD | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dublin Methodist Hospital | Columbus | Ohio | 43016 | United States |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | Pressure 6 mmHg | Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy. |
| FG001 | Pressure 15 mmHg | Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pressure 6 mmHg | Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP. |
| BG001 | Pressure 15 mmHg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | morphine milligram equivalents | Through 1 week postoperatively |
|
Events were tracked through 90 days following discharge via review of medical records
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pressure 6 mmHg | Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epigastric bleed | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Hedgepeth | OhioHealth | 614-788-2870 | ryan.hedgepeth@ohiohealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2020 | Dec 1, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 3, 2020 | Dec 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Pneumoperitoneum Pressure 15 mmHg | Other | A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP). |
|
| 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) |
Pneumoperitoneum Pressure 15 mmHg
Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | Post-operative pain scores were not recorded for one participant in the Pneumoperitoneum pressure 6 mmHg group | Posted | Mean | Standard Deviation | Units on a scale | Through discharge (post-operative day 0 or post-operative day 1) |
|
|
|
| Secondary | Operative Ventilation | Average tidal volume (ml) | Posted | Mean | Standard Deviation | milliliters | 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 | The post-operative discharge day was not recorded for one participant in each group | Posted | Count of Participants | Participants | Through discharge (post-operative day 0 or 1) |
|
|
|
| 1 |
| 68 |
| 1 |
| 68 |
| 0 |
| 68 |
| EG001 | Pressure 15 mmHg | Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy. | 0 | 71 | 0 | 71 | 0 | 71 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |