A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries

Barbara Ann Karmanos Cancer Institute1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2009年5月1日最近更新: 2014年5月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Barbara Ann Karmanos Cancer Institute
入组人数: 6
试验地点: 1
主要终点: Operative time that directly affects operative cost

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•DISEASE CHARACTERISTICS:
•Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes
•Malignant disease must meet the following criteria:
•Histologically confirmed diagnosis of 1 of the following:
•Glottic cancer (T1, T2, and T3)
•Supraglottic cancer (T1, T2, and T3)
•Hypopharyngeal cancer (T1 and T2)
•Oropharyngeal cancer (T1, T2, and T3)
•Nasopharyngeal cancer (T1 and T2)
•Resectable involved lymph nodes
•No invasion of osseous and/or osseocartilaginous structures including the following:
•Mandibular bone
•Thyroid cartilage
•Hyoid bone
•Cricoid bone
•Vertebral body
•No pharyngeal wall or tongue-based involvement requiring resection of > 50% of the posterior pharyngeal wall or tongue base
•No radiological confirmation of carotid artery involvement
•No fixation of tumor to the prevertebral fascia
•No bilateral arytenoid involvement
•No surgical defect requiring open approach for reconstruction
•No evidence of distant metastasis
•PATIENT CHARACTERISTICS:
•Not pregnant
•No unexplained fever and/or untreated active infection
•No medical conditions contraindicating general anesthesia
•No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy
•PRIOR CONCURRENT THERAPY:
•See Disease Characteristics

排除标准

未提供