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NCT01322945 · OUTCOME

Change in Mean Survey Response From Baseline to 90 Days Post Surgery

Barrow Nasal Inventory Survey · Source last updated 2013-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, 90 days post surgery

What was measured

Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.

Analysis population: Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Endonasal Group52
Control Group42

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Endonasal Group17.36.7Not reportedNot reportedNot reported
Control Group13.54.2Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.7
        value
        17.3
      2. group Id
        OG001
        spread
        4.2
        value
        13.5
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      42
    units
    Participants
description
Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.
dispersion Type
Standard Deviation
groups
  1. description
    Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
    id
    OG000
    title
    Endonasal Group
  2. description
    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.
    id
    OG001
    title
    Control Group
param Type
MEAN
population Description
Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.
reporting Status
POSTED
time Frame
Baseline, 90 days post surgery
title
Change in Mean Survey Response From Baseline to 90 Days Post Surgery
type
PRIMARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice