A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of Participants with Esophageal Stricture
研究概览
简要总结
The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. We want to identify patients who will have this procedure. We will look at data elements before, during, and after your procedure to understand the impact of this surgery on your post-operative clinical outcomes.
详细描述
Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract. Different surgical approaches and techniques have been developed, including open (transthoracic or transhiatal), minimally invasive (video-assisted thoracoscopic surgery or robotic-assisted), and hybrid approaches. These techniques may yield different clinical outcomes, and there is still ongoing debate regarding the optimal approach. Nevertheless, minimally invasive approaches, including robotic esophagectomy, are generally preferred given the lower morbidity. This prospective clinical registry aims to investigate outcomes of elective robotic transhiatal esophagectomy, the preferred approach at Northwestern Memorial Hospital, for adult patients undergoing this procedure. By collecting clinical and demographic data prospectively, we hope to identify factors that contribute to improved outcomes and guide future surgical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older)
- •Patients undergoing elective esophagectomy for any indication
- •Patients who have already had an elective esophagectomy for any indication
- •Patients with consent providing capacity
排除标准
- •Patients undergoing emergent esophagectomy
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Vulnerable Populations
结局指标
主要结局
Number of Participants with Esophageal Stricture
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants Requiring Ventilation >48 Hours
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Pulmonary Embolism
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Intensive Care Unit (ICU) Stay
时间窗: During first 3 months postop
Postoperative Complication
Rates of 30-day Survival
时间窗: Postoperative
Postoperative Complication
Rates of 90-day Survival Rates
时间窗: Postoperative
Postoperative Complication
Number of Participants with Anastomotic Leak
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Pneumonia
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Deep Venous Thrombosis
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Stroke
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Myocardial Infarction
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Chylothorax
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Empyema
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Gastric Outlet Obstruction
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Acute Renal Injury
时间窗: During first 3 months postop
Postoperative Complication
Rates of Re-operation
时间窗: During first 3 months postop
Postoperative Complication
Rates of Re-Admission
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Atrial Fibrillation
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Vocal Cord Paralysis
时间窗: During first 3 months postop
Postoperative Complication
Number of Participants with Wound Infections
时间窗: During first 3 months postop
Postoperative Complication
Rates of Length of Hospital Stay
时间窗: Postoperative
Postoperative Complication
次要结局
- Operative Time of Surgery(Intraoperative)
- Number of Participants with Conversion Rates to Open Esophagectomy(Intraoperative)
- Rates of Blood Loss(Intraoperative)
- Number of Participants with Lymph nodes in the Final Specimen(Intraoperative)
- Number of Participants with Proximal and Distal Margins(Intraoperative)
研究者
Ankit Bharat
Chief of Thoracic Surgery
Northwestern University