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NCT01059357 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2018-11-16

The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.

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outcome · POSTED

Operative Time

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outcome · POSTED

Number of Participants With Blood Loss and Complications

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outcome · POSTED

Average Time to Set up and Perform Procedures

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outcome · POSTED

Number of Correctly Predicted Success of TORS Preoperatively

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outcome · POSTED

QOL

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx) * Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation Exclusion Criteria: * Unexplained fever and/or untreated, active infection * Patient pregnancy * Previous head and neck surgery precluding transoral/robotic procedures * The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
    intervention Names
    1. Device: Da Vinci Robotic Transoral Robotic Surgical System
    label
    Transoral Robotic Surgery (TORS)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Transoral Robotic Surgery (TORS)
    description
    (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    name
    Da Vinci Robotic Transoral Robotic Surgical System
    other Names
    1. (TORS) Da Vinci Robotic Transoral Robotic Surgical System
    type
    DEVICE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
58
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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
    measure
    The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
    time Frame
    At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
secondary Outcomes
  1. description
    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.
    measure
    Operative Time
    time Frame
    At time of surgery, up to 3 hours
  2. measure
    Number of Participants With Blood Loss and Complications
    time Frame
    6 months
  3. description
    This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.
    measure
    Average Time to Set up and Perform Procedures
    time Frame
    At time of surgery, up to 3 hours
  4. description
    This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
    measure
    Number of Correctly Predicted Success of TORS Preoperatively
    time Frame
    preoperative
  5. description
    Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
    measure
    QOL
    time Frame
    6 months
Full study description
brief Summary
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
detailed Description
Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-27fa5fcebfbd5099ad1f
      requested nct id
      NCT01059357
      primary nct id
      NCT01059357
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      payload sha256
      84923bcfe14596869d165e41a0a84231c0c9e3c3b851500f96756125b09b6070
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-27fa5fcebfbd5099ad1f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01059357
      occurrences
      1. context exact
        NCT01059357
        end
        11
        exact text
        NCT01059357
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hypopharyngeal Cancer
      query disease state id
      ds-hypopharyngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hypopharyngeal-cancer-000.json
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      source json pointer
      /studies/49/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      f0e5afb9391db8284ab033e1f2c87667d772a68cb7200b00d75fca1d1364ef17

    Preserved source evidence · Not medical advice