Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Conditions
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Esophagectomy

Intervention / Treatment
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* Procedure: Esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients undergoing emergent esophagectomy Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Vulnerable Populations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Esophagectomy|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Anastomotic Leak | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Esophageal Stricture | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Pneumonia | Postoperative Complication | During first 3 months postop | 
| Number of Participants Requiring Ventilation >48 Hours | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Empyema | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Pulmonary Embolism | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Deep Venous Thrombosis | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Gastric Outlet Obstruction | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Stroke | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Atrial Fibrillation | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Vocal Cord Paralysis | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Myocardial Infarction | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Chylothorax | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Acute Renal Injury | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Wound Infections | Postoperative Complication | During first 3 months postop | 
| Rates of Re-operation | Postoperative Complication | During first 3 months postop | 
| Rates of Re-Admission | Postoperative Complication | During first 3 months postop | 
| Number of Participants with Intensive Care Unit (ICU) Stay | Postoperative Complication | During first 3 months postop | 
| Rates of Length of Hospital Stay | Postoperative Complication | Postoperative | 
| Rates of 30-day Survival | Postoperative Complication | Postoperative | 
| Rates of 90-day Survival Rates | Postoperative Complication | Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time of Surgery | Length of Surgery | Intraoperative | 
| Rates of Blood Loss | Did the Participant Lose Any Blood During the Surgery | Intraoperative | 
| Number of Participants with Conversion Rates to Open Esophagectomy |  | Intraoperative | 
| Number of Participants with Lymph nodes in the Final Specimen | Pathological Variables | Intraoperative | 
| Number of Participants with Proximal and Distal Margins | Pathological Variables | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Transhiatal