Lumbar Drain After Endoscopic Surgery of the Skull Base

Quality of Life Clinical Trial

Official title: Lumbar Drain After Endoscopic Surgery of the Skull Base

Status Terminated

Clinical Trial Summary

The overall purpose of this study is to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid leak postoperatively.

Clinical Trial Description

In the past, reconstructions were performed using fat grafts or fascia lata for endoscopic endonasal approach (EEA) surgery. Considerably high postoperative cerebrospinal fluid (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. ;

Related Conditions & MeSH terms

• Quality of Life

• NCT number: NCT03163134
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Terminated
• Phase: N/A
• Start date: December 23, 2010
• Completion date: April 12, 2018