Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors
研究概览
简要总结
RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.
详细描述
PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.
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
- •Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
- •Surgical access is amenable to treatment with conventional transoral surgical procedures
- •ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
- •Patients should have no serious acute infection
- •Patients must sign a study-specific informed consent form
排除标准
- •Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
- •ASA score > 4; ECOG PS score > 3
- •Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
- •The presence of medical conditions which contraindicate general anesthesia
- •Unexplained fever or untreated, active infection
- •Inability to obtain exposure to allow performance of the planned transoral surgical procedure
- •Proposed surgical site with history of prior treatment: radiation
- •Tumor adherent to carotid artery or jugular vein
- •Fixation to pre-vertebral tumor
- •Mandibular invasion
结局指标
主要结局
Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors
时间窗: From 6 months to 3 years after completion of study treatment
Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors
时间窗: From 6 months to 3 years after completion of study treatment
Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors
时间窗: From 6 months to 3 years after completion of study treatment
Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors
时间窗: From 6 months to 3 years after completion of study treatment
Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors
时间窗: From 6 months to 3 years after completion of study treatment
Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS
时间窗: From 6 months to 3 years after completion of study treatment
次要结局
- Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival.(From 6 months to 3 years after completion of study treatment)
- Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments(From 6 months to 3 years after completion of study treatment)