Lumbar Drain After Endoscopic Surgery of the Skull Base

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lumbar Drain After Endoscopic Surgery of the Skull Base

Conditions
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Quality of Life

Intervention / Treatment
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* Device: Lumbar Drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Patients undergoing EEA for resection of brain tumors Dural defect greater than 1cm Extensive arachnoid dissection Dissection into a ventricle or cistern Exclusion Criteria: Less than 18 years of age Spina Bifida

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Lumbar Drain Group<br>Group of patients that did not receive a lumbar drain after surgery | |
| Experimental: Lumbar Drain Group<br>Group of patients that received a lumbar drain after surgery | Device: Lumbar Drain<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Drain, CSF Leak