Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
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|ClinicalTrials.gov Identifier: NCT00918762|
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : May 9, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Perioperative/Postoperative Complications Precancerous Condition||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||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries|
|Study Start Date :||May 2009|
|Primary Completion Date :||February 2010|
|Study Completion Date :||October 2010|
Experimental: daVinci® Robotic Surgical System
Participants will undergo a planned surgical procedures via the robotic approach.
|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|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918762
|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|