Transoral Robotic Surgery Using the Da Vinci Robotic Surgical System in Treating Patients With Benign or Malignant Tumors of the Oral Cavity, Larynx, or Pharynx
This trial is active, not recruiting.
|Condition||head and neck neoplasms|
|Treatment||da vinci robotic transoral robotic surgical system|
|Sponsor||Comprehensive Cancer Center of Wake Forest University|
|Start date||June 2010|
|End date||October 2014|
|Trial size||60 participants|
|Trial identifier||NCT01059357, CCCWFU 60209|
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||single group assignment|
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis.
time frame: 6 months
Secondary outcome measures are operative time, blood loss and complications, to assess the learning curve for TORS by measuring the efficiency and accuracy of the procedures, and to assess the quality of life of the patients undergoing TORS.
time frame: 6 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Patient must present with indications for diagnostic or therapeutic approaches for benign and 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 Exclusion Criteria: - Unexplained fever and/or untreated, active infection - Patient pregnancy - Previous head and neck surgery precluding transoral/robotic procedures - The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
|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|
|Principal investigator||Joshua D. Waltonen, MD|
|Description||Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).|
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