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Lumbar Drain After Endoscopic Surgery of the Skull Base

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ClinicalTrials.gov Identifier: NCT03163134
Recruitment Status : Terminated (Due to the fact data results were statistically significant among the two groups)
First Posted : May 22, 2017
Results First Posted : August 16, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Gardner, 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.

Condition or disease Intervention/treatment Phase
Quality of Life Device: Lumbar Drain Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Lumbar Drain After Endoscopic Surgery of the Skull Base
Actual Study Start Date : February 3, 2011
Actual Primary Completion Date : April 27, 2015
Actual Study Completion Date : April 27, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
No Intervention: No Lumbar Drain Group
Group of patients that did not receive a lumbar drain after surgery
Experimental: Lumbar Drain Group
Group of patients that received a lumbar drain after surgery
Device: Lumbar Drain



Primary Outcome Measures :
  1. Number of Participants With Cerebrospinal Fluid (CSF) Leak [ Time Frame: 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 :
  1. Number of Participants With Postoperative Complications [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163134


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Paul Gardner, MD University of Pittsburgh

Responsible Party: Paul Gardner, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03163134     History of Changes
Other Study ID Numbers: PRO10030258
First Posted: May 22, 2017    Key Record Dates
Results First Posted: August 16, 2017
Last Update Posted: August 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Paul Gardner, University of Pittsburgh:
Lumbar Drain, CSF Leak