RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors. PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.
OBJECTIVES: Primary * Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx. Secondary * Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach. OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference. Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach. Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow. After completion of study procedure, patients are followed at 3 and 6 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Operative time that directly affects operative cost
Time frame: post operative
Blood loss
Time frame: During surgery
Intra-operative and post-operative complications
Time frame: during the operation and post operative
Need for reconstruction
Time frame: post operative
Margins status
Time frame: post operative
Length of hospital stay
Time frame: during time as inpatient
Tracheostomy and PEG dependence
Time frame: post operative
Days to oral intake
Time frame: post operative
Time to locoregional recurrence
Time frame: post operative
Speech intelligibility
Time frame: post operative
Quality of life
Time frame: 3 months and 6 month following completion of surgery
Postoperative pain
Time frame: post operative
Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion
Time frame: post operative
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