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NCT00068237 · OUTCOME

Percentage of Patients With Normal Functioning Transferred Submandibular Gland

Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer · Source last updated 2019-02-05

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)

What was measured

Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.

Analysis population: Eligible patients with salivary scans submitted

Groups in this outcome

Surgery + Transfer + Radiation

Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.

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

Analysis denominator · Participants

GroupSource count
Surgery + Transfer + Radiation37

Reported measurements

Pre-surgery

Analysis denominator · Participants

GroupSource count
Surgery + Transfer + Radiation37
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Surgery + Transfer + Radiation70.3Not reported55.585.0Not reported
Post-surgery

Analysis denominator · Participants

GroupSource count
Surgery + Transfer + Radiation36
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Surgery + Transfer + Radiation16.7Not reported4.528.8Not reported
Post-radiotherapy

Analysis denominator · Participants

GroupSource count
Surgery + Transfer + Radiation27
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Surgery + Transfer + Radiation0.0Not reported0.00.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.5
        upper Limit
        85.0
        value
        70.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Pre-surgery
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.5
        upper Limit
        28.8
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Post-surgery
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Post-radiotherapy
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.
dispersion Type
95% Confidence Interval
groups
  1. description
    Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
    id
    OG000
    title
    Surgery + Transfer + Radiation
param Type
NUMBER
population Description
Eligible patients with salivary scans submitted
reporting Status
POSTED
time Frame
Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
title
Percentage of Patients With Normal Functioning Transferred Submandibular Gland
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice