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NCT01059357 · STUDY IN CONTEXT

Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis

Source null

→

secondary · POSTED

The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.

Source null

→

secondary · POSTED

Number of Participants With Blood Loss and Complications

Source null

→

secondary · POSTED

This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.

Source null

→

secondary · POSTED

This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.

Source null

→

secondary · POSTED

Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.

Data not collected on all participants

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · QOL

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01059357
qol key
qol-0005
source section id
NCT01059357-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
QOL
measure definition
Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
time frame
6 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores denoting better
population note
Data not collected on all participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT01059357
trial label
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0000
    source section id
    NCT01059357-om-0000
    source outcome index
    0
    endpoint
    The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
    endpoint definition
    In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis
    time origin
    At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0001
    source section id
    NCT01059357-om-0001
    source outcome index
    1
    endpoint
    Operative Time
    endpoint definition
    The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.
    time origin
    At time of surgery, up to 3 hours
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0002
    source section id
    NCT01059357-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Blood Loss and Complications
    endpoint definition
    Number of Participants With Blood Loss and Complications
    time origin
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0003
    source section id
    NCT01059357-om-0003
    source outcome index
    3
    endpoint
    Average Time to Set up and Perform Procedures
    endpoint definition
    This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.
    time origin
    At time of surgery, up to 3 hours
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0004
    source section id
    NCT01059357-om-0004
    source outcome index
    4
    endpoint
    Number of Correctly Predicted Success of TORS Preoperatively
    endpoint definition
    This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
    time origin
    preoperative
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0005
    source section id
    NCT01059357-om-0005
    source outcome index
    5
    endpoint
    QOL
    endpoint definition
    Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
    time origin
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected on all participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Transoral Robotic Surgery (TORS)
    regimen
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    analyzed count
    58
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01059357-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Transoral Robotic Surgery (TORS)
    regimen
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01059357-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Transoral Robotic Surgery (TORS)
    regimen
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01059357-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Transoral Robotic Surgery (TORS)
    regimen
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01059357-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Transoral Robotic Surgery (TORS)
    regimen
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01059357-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Transoral Robotic Surgery (TORS)
    regimen
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01059357-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    harm key
    EG000
    source section id
    NCT01059357-ae
    event group key
    EG000
    event group label
    Transoral Robotic Surgery (TORS)
    serious affected
    0
    serious at risk
    54
    other affected
    7
    other at risk
    54
    frequency threshold
    2
    collection period
    up to 6 months
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT01059357
    qol key
    qol-0005
    source section id
    NCT01059357-om-0005
    source outcome index
    5
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    QOL
    measure definition
    Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
    time frame
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores denoting better
    population note
    Data not collected on all participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice