Lumbar Drain After Endoscopic Surgery of the Skull Base

University of Pittsburgh

Status: Terminated

Conditions: Quality of Life

Treatments: Device: Lumbar Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT03163134

PRO10030258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups

No Lumbar Drain Group

No Intervention group

Description:

Group of patients that did not receive a lumbar drain after surgery

Lumbar Drain Group

Experimental group

Description:

Group of patients that received a lumbar drain after surgery

Treatment:

Device: Lumbar Drain