Study Stopped
Due to the fact data results were statistically significant among the two groups
Lumbar Drain After Endoscopic Surgery of the Skull Base
1 other identifier
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Feb 2011
Longer than P75 for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2015
CompletedFirst Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedResults Posted
Study results publicly available
August 16, 2017
CompletedAugust 16, 2017
May 1, 2017
4.2 years
May 19, 2017
May 26, 2017
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Cerebrospinal Fluid (CSF) Leak
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.
1month
Secondary Outcomes (1)
Number of Participants With Postoperative Complications
1 year
Study Arms (2)
No Lumbar Drain Group
NO INTERVENTIONGroup of patients that did not receive a lumbar drain after surgery
Lumbar Drain Group
EXPERIMENTALGroup of patients that received a lumbar drain after surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Less than 18 years of age
- Spina Bifida
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 30485224DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benita Valappil
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Gardner, MD
University of Pittsburgh Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 19, 2017
First Posted
May 22, 2017
Study Start
February 3, 2011
Primary Completion
April 27, 2015
Study Completion
April 27, 2015
Last Updated
August 16, 2017
Results First Posted
August 16, 2017
Record last verified: 2017-05