Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck (NCT01473784) | Clinical Trial Compass
RecruitingNot Applicable
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
United States600 participantsStarted 2007-12-03
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
Timeframe: up to eight years
Trial details
NCT IDNCT01473784
SponsorOhio State University Comprehensive Cancer Center