Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Esophagectomy Clinical Trial

Official title:

A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950438
• Other study ID #: STU00219267
• Status: Recruiting
• Start date: July 11, 2023
• Est. completion date: May 25, 2028

Study information

• Verified date: July 2023
• Source: Northwestern University
• Contact: Ankit Bharat, MD
• Phone: 312-926-7628
• Email: ankit.bharat[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 25, 2028
• Est. primary completion date: May 25, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagectomy

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Anastomotic Leak	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Esophageal Stricture	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Pneumonia	Postoperative Complication	During first 3 months postop
Primary	Number of Participants Requiring Ventilation >48 Hours	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Empyema	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Pulmonary Embolism	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Deep Venous Thrombosis	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Gastric Outlet Obstruction	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Stroke	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Atrial Fibrillation	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Vocal Cord Paralysis	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Myocardial Infarction	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Chylothorax	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Acute Renal Injury	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Wound Infections	Postoperative Complication	During first 3 months postop
Primary	Rates of Re-operation	Postoperative Complication	During first 3 months postop
Primary	Rates of Re-Admission	Postoperative Complication	During first 3 months postop
Primary	Number of Participants with Intensive Care Unit (ICU) Stay	Postoperative Complication	During first 3 months postop
Primary	Rates of Length of Hospital Stay	Postoperative Complication	Postoperative
Primary	Rates of 30-day Survival	Postoperative Complication	Postoperative
Primary	Rates of 90-day Survival Rates	Postoperative Complication	Postoperative
Secondary	Operative Time of Surgery	Length of Surgery	Intraoperative
Secondary	Rates of Blood Loss	Did the Participant Lose Any Blood During the Surgery	Intraoperative
Secondary	Number of Participants with Conversion Rates to Open Esophagectomy		Intraoperative
Secondary	Number of Participants with Lymph nodes in the Final Specimen	Pathological Variables	Intraoperative
Secondary	Number of Participants with Proximal and Distal Margins	Pathological Variables	Intraoperative