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Due to the fact data results were statistically significant among the two groups
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The overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak postoperatively and promote a standardization of its use.
In the past, reconstructions were performed using fat grafts or fascia lata for EEA surgery. Considerably high postoperative CSF leaks were reported and were a major cause of concern due CSF fistula increasing risk of infection. Since external lumbar drain can lower CSF pressure and is believed to prevent post operative CSF leak, it was used commonly after EEA. With improvements in EEA skull base reconstructions using a nasal septal flap in the recent years, postoperative CSF leaks have been reported in much lower rates. With this improvement in reconstruction techniques, the use of lumbar drain may not be necessary as it may not significantly lower the risk of CSF leak further. In this prospective randomized study, we will randomize subjects at high risk for CSF leak to either receive a prophylactic lumbar drain or to not receive a prophylactic lumbar drain and compare the rate of CSF leaks and other complications in the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Lumbar Drain Group | No Intervention | Group of patients that did not receive a lumbar drain after surgery | |
| Lumbar Drain Group | Experimental | Group of patients that received a lumbar drain after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Drain | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cerebrospinal Fluid (CSF) Leak | Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement. | 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Complications | Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Gardner, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30485224 | Derived | Zwagerman NT, Wang EW, Shin SS, Chang YF, Fernandez-Miranda JC, Snyderman CH, Gardner PA. Does lumbar drainage reduce postoperative cerebrospinal fluid leak after endoscopic endonasal skull base surgery? A prospective, randomized controlled trial. J Neurosurg. 2018 Oct 19;131(4):1172-1178. doi: 10.3171/2018.4.JNS172447. Print 2019 Oct 1. |
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All adult patients undergoing endoscopic endonasal approach (EEA) at the Center for Cranial Base Surgery of the University of Pittsburgh Medical Center from February 2011 to April 2015 were evaluated for enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Lumbar Drain Group | Group of patients that did not receive a lumbar drain after surgery |
| FG001 | Lumbar Drain Group | Group of patients that received a lumbar drain after surgery Lumbar Drain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Lumbar Drain Group | Group of patients that did not receive a lumbar drain after surgery. |
| BG001 | Lumbar Drain Group | Group of patients that received a lumbar drain after surgery. Lumbar Drain |
| 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 | Number of Participants With Cerebrospinal Fluid (CSF) Leak | Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement. | Posted | Count of Participants | Participants | 1month |
|
Three times a year
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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 | No Lumbar Drain Group | Group of patients that did not receive a lumbar drain after surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benita Valappil | University of Pittsburgh | 412.864.1744 | valappilb2@upmc.edu |
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| ID | Term |
|---|---|
| D002558 | Cerebrospinal Fluid Otorrhea |
| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Postoperative Complications | Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | Lumbar Drain Group | Group of patients that received a lumbar drain after surgery Lumbar Drain | 0 | 85 | 0 | 85 | 0 | 85 |
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| D020196 | Trauma, Nervous System |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |