Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Participants with Anastomotic Leak [During first 3 months postop]
Postoperative Complication
- Number of Participants with Esophageal Stricture [During first 3 months postop]
Postoperative Complication
- Number of Participants with Pneumonia [During first 3 months postop]
Postoperative Complication
- Number of Participants Requiring Ventilation >48 Hours [During first 3 months postop]
Postoperative Complication
- Number of Participants with Empyema [During first 3 months postop]
Postoperative Complication
- Number of Participants with Pulmonary Embolism [During first 3 months postop]
Postoperative Complication
- Number of Participants with Deep Venous Thrombosis [During first 3 months postop]
Postoperative Complication
- Number of Participants with Gastric Outlet Obstruction [During first 3 months postop]
Postoperative Complication
- Number of Participants with Stroke [During first 3 months postop]
Postoperative Complication
- Number of Participants with Atrial Fibrillation [During first 3 months postop]
Postoperative Complication
- Number of Participants with Vocal Cord Paralysis [During first 3 months postop]
Postoperative Complication
- Number of Participants with Myocardial Infarction [During first 3 months postop]
Postoperative Complication
- Number of Participants with Chylothorax [During first 3 months postop]
Postoperative Complication
- Number of Participants with Acute Renal Injury [During first 3 months postop]
Postoperative Complication
- Number of Participants with Wound Infections [During first 3 months postop]
Postoperative Complication
- Rates of Re-operation [During first 3 months postop]
Postoperative Complication
- Rates of Re-Admission [During first 3 months postop]
Postoperative Complication
- Number of Participants with Intensive Care Unit (ICU) Stay [During first 3 months postop]
Postoperative Complication
- Rates of Length of Hospital Stay [Postoperative]
Postoperative Complication
- Rates of 30-day Survival [Postoperative]
Postoperative Complication
- Rates of 90-day Survival Rates [Postoperative]
Postoperative Complication
Secondary Outcome Measures
- Operative Time of Surgery [Intraoperative]
Length of Surgery
- Rates of Blood Loss [Intraoperative]
Did the Participant Lose Any Blood During the Surgery
- Number of Participants with Conversion Rates to Open Esophagectomy [Intraoperative]
- Number of Participants with Lymph nodes in the Final Specimen [Intraoperative]
Pathological Variables
- Number of Participants with Proximal and Distal Margins [Intraoperative]
Pathological Variables
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (18 years or older)
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Patients undergoing elective esophagectomy for any indication
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Patients who have already had an elective esophagectomy for any indication
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Patients with consent providing capacity
Exclusion Criteria:
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Patients undergoing emergent esophagectomy
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Adults unable to consent
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Individuals who are not yet adults (infants, children, teenagers)
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Pregnant women
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Prisoners
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Vulnerable Populations
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Ankit Bharat, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00219267