Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
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.
Head and Neck Cancer
Procedure: assessment of therapy complications
Procedure: diagnostic endoscopic surgery
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Procedure: therapeutic endoscopic surgery
Procedure: transoral robotic surgery
Procedure: video-assisted surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries|
- Operative time that directly affects operative cost [ Designated as safety issue: No ]
- Blood loss [ Designated as safety issue: Yes ]
- Intra-operative and post-operative complications [ Designated as safety issue: Yes ]
- Need for reconstruction [ Designated as safety issue: No ]
- Margins status [ Designated as safety issue: No ]
- Length of hospital stay [ Designated as safety issue: No ]
- Tracheostomy and PEG dependence [ Designated as safety issue: No ]
- Days to oral intake [ Designated as safety issue: No ]
- Time to locoregional recurrence [ Designated as safety issue: No ]
- Speech intelligibility [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Postoperative pain [ Designated as safety issue: No ]
- Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Principal Investigator:||Ho-Sheng Lin, MD||Barbara Ann Karmanos Cancer Institute|