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Trial record 34 of 156 for:    pituitary tumor

Barrow Nasal Inventory Survey (BNI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01322945
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Pituitary Tumors

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.

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
Endonasal Group Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
Control Group Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.

Participant Flow:   Overall Study
    Endonasal Group   Control Group
STARTED   52   42 
COMPLETED   52   42 
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
Endonasal Group Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
Control Group Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
Total Total of all reporting groups

Baseline Measures
   Endonasal Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   42   94 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   41   32   73 
>=65 years   11   10   21 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (15.49)   54.17  (14.83)   50.27  (15.26) 
Gender 
[Units: Participants]
     
Female   25   24   49 
Male   27   18   45 
Region of Enrollment 
[Units: Participants]
     
United States   52   42   94 


  Outcome Measures

1.  Primary:   Change in Mean Survey Response From Baseline to 90 Days Post Surgery   [ Time Frame: Baseline, 90 days post surgery ]

2.  Secondary:   Test-retest Reliability of the ASK Nasal Inventory   [ Time Frame: 90 days and 120 days post surgery ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew S. Little, MD
Organization: Barrow Neurological Institute
phone: 602-406-3181
e-mail: heidi.jahnke@dignityhealth.org


Publications of Results:

Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01322945     History of Changes
Other Study ID Numbers: 10BN172
First Submitted: March 23, 2011
First Posted: March 25, 2011
Results First Submitted: January 30, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013