Tongue Cancer Clinical Trial
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
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
| Status | Recruiting |
| Enrollment | 360 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Medical Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. | up to eight years | ||
| Secondary | Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. | If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.
2. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures. |
up to eight years | |
| Secondary | Assess the quality of life of the patients with TORS. | up to eight years |
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