Lumbar Drain After Endoscopic Surgery of the Skull Base

NCT ID: NCT03163134

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-03
• Study Completion Date: 2015-04-27

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.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

No Lumbar Drain Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lumbar Drain Group

Group of patients that received a lumbar drain after surgery

Group Type: EXPERIMENTAL

Lumbar Drain

Intervention Type: DEVICE

Interventions

Lumbar Drain

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Paul Gardner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Gardner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30485224 (View on PubMed)

Other Identifiers

PRO10030258

Identifier Type: -

Identifier Source: org_study_id