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Funding support unavailable
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Participants to be enrolled in this study will have been scheduled to have laparoscopic genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively. Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries due to intraoperative positioning.
Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine the incidence and potential causes of significant changes in SSEP waveforms and correlate these changes with neurologic status of the brachial plexus after robotic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | Other | All participants will be monitored with EPAD system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPAD monitoring system | Device | EPAD system will be used as part of routine care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Somatosensory Evoked Potential Monitoring | Recording of somatosensory evoked potential in patients undergoing genitourinary surgery | in the first 24 hours of postoperative period |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with previous history of polyneuropathy, carpal tunnel, ulnar neuropathy, or similar neurological deficiencies
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| Name | Affiliation | Role |
|---|---|---|
| Robert McClain, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observation | All participants will be monitored with EPAD system EPAD monitoring system: EPAD system will be used as part of routine care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observation | All participants will be monitored with EPAD system EPAD monitoring system: EPAD system will be used as part of routine care |
| 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 | Somatosensory Evoked Potential Monitoring | Recording of somatosensory evoked potential in patients undergoing genitourinary surgery | Study terminated prematurely. Data was not collected. | Posted | in the first 24 hours of postoperative period |
|
|
Adverse Events were collected over a 24 hour period.
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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 | Observation | All participants will be monitored with EPAD system EPAD monitoring system: EPAD system will be used as part of routine care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert L. McClain, M.D. | Mayo Clinic | 904-956-1728 | Mcclain.Robert@mayo.edu |
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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 | May 4, 2017 | Oct 7, 2019 | Prot_SAP_000.pdf |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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