NCT00918762已完成1 期
A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Operative time that directly affects operative cost
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Operative time that directly affects operative cost
时间窗: post operative
次要结局
- Intra-operative and post-operative complications(during the operation and post operative)
- Margins status(post operative)
- Blood loss(During surgery)
- Length of hospital stay(during time as inpatient)
- Need for reconstruction(post operative)
- Tracheostomy and PEG dependence(post operative)
- Days to oral intake(post operative)
- Speech intelligibility(post operative)
- Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion(post operative)
- Time to locoregional recurrence(post operative)
- Quality of life(3 months and 6 month following completion of surgery)
- Postoperative pain(post operative)
研究者
Ho-Sheng Lin
Principal Investigator
Barbara Ann Karmanos Cancer Institute
研究点 (2)
Loading locations...
相似试验
终止
不适用
Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive TractHypopharyngeal NeoplasmsLaryngeal NeoplasmsHead and Neck CancersNCT00721539Stanford University9
Unknown
不适用
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck SurgeryHead and Neck NeoplasmsNCT00627562Montefiore Medical Center71
招募中
不适用
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and NeckStage 0 Laryngeal CancerStage 0 Lip and Oral Cavity CancerStage I Adenoid Cystic Carcinoma of the Oral CavityStage I Mucoepidermoid Carcinoma of the Oral CavityStage I Squamous Cell Carcinoma of the HypopharynxStage I Squamous Cell Carcinoma of the LarynxRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage 0 Hypopharyngeal CancerStage I Squamous Cell Carcinoma of the Lip and Oral CavityStage I Verrucous Carcinoma of the LarynxStage I Verrucous Carcinoma of the Oral CavityStage II Adenoid Cystic Carcinoma of the Oral CavityStage II Mucoepidermoid Carcinoma of the Oral CavityStage II Squamous Cell Carcinoma of the HypopharynxStage II Squamous Cell Carcinoma of the LarynxStage II Squamous Cell Carcinoma of the Lip and Oral CavityStage II Verrucous Carcinoma of the LarynxStage II Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IVA Adenoid Cystic Carcinoma of the Oral CavityStage IVA Mucoepidermoid Carcinoma of the Oral CavityStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Adenoid Cystic Carcinoma of the Oral CavityStage IVB Mucoepidermoid Carcinoma of the Oral CavityStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Adenoid Cystic Carcinoma of the Oral CavityStage IVC Mucoepidermoid Carcinoma of the Oral CavityStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue CancerNCT01473784Ohio State University Comprehensive Cancer Center600
已完成
不适用
Clinical utility of robotic surgery (the da Vinci® surgical system; standard and S) for the treatment of lung and mediastinal diseaselung and mediastinal diseaseJPRN-UMIN000004328Tokyo medical university, department of general thoracic surgery30
已完成
不适用
Prospective, Multicenter da Vinci® SP™ Surgical System TORS StudyOropharyngeal CancerNCT03049280Intuitive Surgical33