A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
Study Overview
Brief 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Transoral robotic surgery (TORS)
Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. 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.
Intervention: transoral robotic surgery (Procedure)
Transoral robotic surgery (TORS)
Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. 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.
Intervention: quality of life assessment (Procedure)
Outcomes
Primary Outcomes
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
Time Frame: up to eight years
Secondary Outcomes
- Assess the quality of life of the patients with TORS.(up to eight years)
- Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.(up to eight years)
Investigators
Enver Ozer
Principal Investigator
Ohio State University Comprehensive Cancer Center