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Procedure

Robotic Surgery for Head and Neck Cancer

N/A
Recruiting
Led By Enver Ozer, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
Be older than 18 years old
Must not have
INTRAOPERATIVE EXCLUSION CRITERIA: Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to eight years
Awards & highlights

Summary

This trial is studying TORS, a less invasive type of surgery for head and neck cancer that may have fewer side effects and improve recovery.

Who is the study for?
This trial is for patients with benign or malignant tumors in the mouth or throat area who need diagnostic or therapeutic procedures. They must be able to have their oral cavity and throat accessed transorally for robotic surgery, and provide informed consent. Pregnant individuals, those with unexplained fevers, active infections, previous surgeries that interfere with this procedure, conditions contraindicating general anesthesia or transoral surgery are excluded.
What is being tested?
The study is examining the effectiveness of Transoral Robotic Surgery (TORS) on patients with head and neck tumors. TORS is a less invasive surgical method which may reduce side effects and improve recovery compared to traditional surgeries.
What are the potential side effects?
While TORS aims to minimize side effects by being less invasive than conventional surgery, potential risks could include bleeding, infection at the surgical site, pain or discomfort from the procedure, swelling, difficulty swallowing temporarily after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My mouth and throat area can be easily accessed for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
Doctors can't see inside my body well enough to do surgery through my mouth.
Select...
I cannot have general anesthesia or certain throat surgeries due to my health conditions.
Select...
I have a fever or an active infection that hasn't been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to eight years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to eight years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transoral robotic surgery (TORS)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
quality of life assessment
2006
Completed Phase 3
~940
transoral robotic surgery
2009
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
334 Previous Clinical Trials
291,248 Total Patients Enrolled
Enver Ozer, MD5.07 ReviewsPrincipal Investigator - Ohio State University
Ohio State University Comprehensive Cancer Center
1 Previous Clinical Trials
11 Total Patients Enrolled
5Patient Review
I had a great experience with both the physician and nursing staff. They were very informative and answered all of my questions. I would definitely recommend them to anyone.

Media Library

Transoral Robotic Surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01473784 — N/A
Verrucous Carcinoma Research Study Groups: Transoral robotic surgery (TORS)
Verrucous Carcinoma Clinical Trial 2023: Transoral Robotic Surgery Highlights & Side Effects. Trial Name: NCT01473784 — N/A
Transoral Robotic Surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01473784 — N/A
~20 spots leftby Sep 2025
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