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Recruiting NCT01473784

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

No phase Interventional Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Recurrent Mucoepidermoid Carcinoma of the Oral Cavity Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transoral robotic surgery, quality of life assessment.
Who it may be relevant to
Registry conditions: Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System

Overview

This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery

Detailed description

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

Interventions

  • Procedure transoral robotic surgery
    Undergo TORS using the Da Vinci Robotic Surgical System
  • Procedure quality of life assessment
    After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.

Primary outcome measures

  • Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [Time frame: up to eight years]
Secondary outcome measures (2)
  • Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. [Time frame: up to eight years]
  • Assess the quality of life of the patients with TORS. [Time frame: up to eight years]

Eligibility criteria

Inclusion criteria

  • Patient must present with indications for diagnostic or therapeutic approaches for benign and/or 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
  • Written informed consent and/or Consent waiver by institutional review board (IRB)

Exclusion criteria

  • Unexplained fever and/or untreated, active infection
  • Patient pregnancy
  • Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
  • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
  • Inability to grant informed consent
  • INTRAOPERATIVE EXCLUSION CRITERIA:
  • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Ohio State University Medical Center — Columbus

Identifiers

NCT: NCT01473784 · OSU-07061 · NCI-2011-03122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗