Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Recruiting

• Conditions: Esophagectomy

• Registration Number: NCT05950438
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study Start: 2023-07-11
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2028-05-25
• Study Completion: 2028-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Esophageal Stricture	During first 3 months postop	Postoperative Complication
Number of Participants with Stroke	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 Wound Infections	During first 3 months postop	Postoperative Complication
Number of Participants with Pneumonia	During first 3 months postop	Postoperative Complication
Number of Participants with Deep Venous Thrombosis	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 Pulmonary Embolism	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 30-day Survival	Postoperative	Postoperative Complication
Rates of 90-day Survival Rates	Postoperative	Postoperative Complication
Number of Participants with Anastomotic Leak	During first 3 months postop	Postoperative Complication
Number of Participants with Empyema	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 Acute Renal Injury	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 Vocal Cord Paralysis	During first 3 months postop	Postoperative Complication
Number of Participants with Atrial Fibrillation	During first 3 months postop	Postoperative Complication
Rates of Length of Hospital Stay	Postoperative	Postoperative Complication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States