Lumbar Drain After Endoscopic Surgery of the Skull Base

Not Applicable

Terminated

• Conditions: Quality of Life
• Interventions: Device: Lumbar Drain

• Registration Number: NCT03163134
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02-03
• Primary Completion: 2015-04-27
• Study Completion: 2015-04-27
• Status Verified: 2017-05
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Results First Submitted: 2017-05-26
• Results First Submitted QC: 2017-07-17
• Last Update Submitted: 2017-07-17
• Results First Posted: 2017-08-16
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar Drain Group	Lumbar Drain	Group of patients that received a lumbar drain after surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cerebrospinal Fluid (CSF) Leak	1month	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Complications	1 year	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.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States