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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Quality of Life
Intervention: Device: Lumbar Drain

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All adult patients undergoing endoscopic endonasal approach (EEA) at the Center for Cranial Base Surgery of the University of Pittsburgh Medical Center from February 2011 to April 2015 were evaluated for enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Lumbar Drain Group Group of patients that did not receive a lumbar drain after surgery
Lumbar Drain Group

Group of patients that received a lumbar drain after surgery

Lumbar Drain


Participant Flow:   Overall Study
    No Lumbar Drain Group   Lumbar Drain Group
STARTED   85   85 
COMPLETED   85   85 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Lumbar Drain Group Group of patients that did not receive a lumbar drain after surgery.
Lumbar Drain Group

Group of patients that received a lumbar drain after surgery.

Lumbar Drain

Total Total of all reporting groups

Baseline Measures
   No Lumbar Drain Group   Lumbar Drain Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   85   170 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (15.11)   51  (15.49)   52  (15.30) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      49  57.6%      56  65.9%      105  61.8% 
Male      36  42.4%      29  34.1%      65  38.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   85   85   170 


  Outcome Measures

1.  Primary:   Number of Participants With Cerebrospinal Fluid (CSF) Leak   [ Time Frame: 1month ]

2.  Secondary:   Number of Participants With Postoperative Complications   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Benita Valappil
Organization: University of Pittsburgh
phone: 412.864.1744
e-mail: valappilb2@upmc.edu



Responsible Party: Paul Gardner, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03163134     History of Changes
Other Study ID Numbers: PRO10030258
First Submitted: May 19, 2017
First Posted: May 22, 2017
Results First Submitted: May 26, 2017
Results First Posted: August 16, 2017
Last Update Posted: August 16, 2017