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NCT00473564 · OUTCOME

Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery · Source last updated 2016-03-08

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
3 - 24 months postoperatively

What was measured

Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

Analysis population: Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System

Groups in this outcome

TORS Candidates

Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

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

Analysis denominator · Participants

GroupSource count
TORS Candidates147

Reported measurements

Known complication: oral hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TORS Candidates17Not reportedNot reportedNot reportedNot reported
Known complication: injury to perioral structures
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TORS Candidates1Not reportedNot reportedNot reportedNot reported
Known complication: airway edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TORS Candidates14Not reportedNot reportedNot reportedNot reported
Known complication: nerve injury
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TORS Candidates1Not reportedNot reportedNot reportedNot reported
Need for conversion to open procedure during surge
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TORS Candidates1Not reportedNot reportedNot reportedNot reported
Need for re-exicision due to positive margins
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TORS Candidates11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Known complication: oral hemorrhage
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Known complication: injury to perioral structures
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Known complication: airway edema
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Known complication: nerve injury
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Need for conversion to open procedure during surge
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Need for re-exicision due to positive margins
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    units
    Participants
description
Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins
groups
  1. description
    Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
    id
    OG000
    title
    TORS Candidates
param Type
NUMBER
population Description
Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System
reporting Status
POSTED
time Frame
3 - 24 months postoperatively
title
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice