Using robotic surgery to treat tumors in the head and neck
A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
This study is testing if using robotic surgery to remove tumors in the mouth and throat can help patients recover faster and feel better afterwards.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT01473784 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the effectiveness of transoral robotic surgery (TORS) for patients with benign or malignant tumors in the oral cavity and laryngopharynx. The study utilizes the Da Vinci Robotic Surgical System to perform less invasive surgical procedures, which may lead to fewer side effects and improved recovery times. Participants will undergo surgery and have their quality of life assessed post-procedure to determine the impact of TORS on their health outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with benign or malignant tumors of the oral cavity or laryngopharynx who can safely undergo transoral robotic surgery.
Not a fit: Patients with active infections, pregnancy, or previous surgeries that prevent transoral approaches may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for patients with head and neck tumors.
How similar studies have performed: Other studies have shown promising results with robotic surgery in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Enver Ozer, MD — Ohio State University
- Study coordinator: Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 1-800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.