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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
Enrollment 170
Recruitment Details 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  
Arm/Group Title No Lumbar Drain Group Lumbar Drain Group
Hide Arm/Group Description Group of patients that did not receive a lumbar drain after surgery

Group of patients that received a lumbar drain after surgery

Lumbar Drain

Period Title: Overall Study
Started 85 85
Completed 85 85
Not Completed 0 0
Arm/Group Title No Lumbar Drain Group Lumbar Drain Group Total
Hide Arm/Group Description Group of patients that did not receive a lumbar drain after surgery.

Group of patients that received a lumbar drain after surgery.

Lumbar Drain

Total of all reporting groups
Overall Number of Baseline Participants 85 85 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 85 participants 170 participants
52  (15.11) 51  (15.49) 52  (15.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
Female
49
  57.6%
56
  65.9%
105
  61.8%
Male
36
  42.4%
29
  34.1%
65
  38.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 85 participants 85 participants 170 participants
85
 100.0%
85
 100.0%
170
 100.0%
1.Primary Outcome
Title Number of Participants With Cerebrospinal Fluid (CSF) Leak
Hide Description 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.
Time Frame 1month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lumbar Drain Group Lumbar Drain Group
Hide Arm/Group Description:
Group of patients that did not receive a lumbar drain after surgery.

Group of patients that received a lumbar drain after surgery.

Lumbar Drain

Overall Number of Participants Analyzed 85 85
Measure Type: Count of Participants
Unit of Measure: Participants
18
  21.2%
7
   8.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lumbar Drain Group, Lumbar Drain Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Postoperative Complications
Hide Description 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.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lumbar Drain Group Lumbar Drain Group
Hide Arm/Group Description:
Group of patients that did not receive a lumbar drain after surgery.

Group of patients that received a lumbar drain after surgery.

Lumbar Drain

Overall Number of Participants Analyzed 85 85
Measure Type: Count of Participants
Unit of Measure: Participants
17
  20.0%
20
  23.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lumbar Drain Group, Lumbar Drain Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.577
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Three times a year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Lumbar Drain Group Lumbar Drain Group
Hide Arm/Group Description Group of patients that did not receive a lumbar drain after surgery

Group of patients that received a lumbar drain after surgery

Lumbar Drain

All-Cause Mortality
No Lumbar Drain Group Lumbar Drain Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/85 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
No Lumbar Drain Group Lumbar Drain Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Lumbar Drain Group Lumbar Drain Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/85 (0.00%) 
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
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