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

Not Applicable

Recruiting

• Conditions: Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage 0 Lip and Oral Cavity Cancer; Stage I Squamous Cell Carcinoma of the Hypopharynx; Stage II Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
• Interventions: Procedure: transoral robotic surgery; Procedure: quality of life assessment

• Registration Number: NCT01473784
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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 Timeline

• Study Start: 2007-12-03
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-09-10
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transoral robotic surgery (TORS)	quality of life assessment	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.
Transoral robotic surgery (TORS)	transoral robotic surgery	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.

Primary Outcome Measures

Name	Time	Method
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.	up to eight years

Secondary Outcome Measures

Name	Time	Method
Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.	up to eight years	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.
Assess the quality of life of the patients with TORS.	up to eight years

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States