A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
研究概览
简要总结
This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery
详细描述
To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
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
- •Patient must present with indications for diagnostic or therapeutic approaches for benign and/or 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
- •Written informed consent and/or Consent waiver by institutional review board (IRB)
排除标准
- •Unexplained fever and/or untreated, active infection
- •Patient pregnancy
- •Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
- •The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
- •Inability to grant informed consent
- •INTRAOPERATIVE EXCLUSION CRITERIA:
- •Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
研究组 & 干预措施
Transoral robotic surgery (TORS)
Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
干预措施: transoral robotic surgery (Procedure)
Transoral robotic surgery (TORS)
Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
干预措施: quality of life assessment (Procedure)
结局指标
主要结局
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
时间窗: up to eight years
次要结局
- Assess the quality of life of the patients with TORS.(up to eight years)
- Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.(up to eight years)
研究者
Enver Ozer
Principal Investigator
Ohio State University Comprehensive Cancer Center