Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

NCT05950438 | Recruiting

• 1 other identifier: STU00219267
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagectomy

Keywords

Robotic Transhiatal

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (5)

• Operative Time of Surgery

  Intraoperative

• Rates of Blood Loss

  Intraoperative

• Number of Participants with Conversion Rates to Open Esophagectomy

  Intraoperative

• Number of Participants with Lymph nodes in the Final Specimen

  Intraoperative

• Number of Participants with Proximal and Distal Margins

  Intraoperative

Interventions

Esophagectomy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be identified in the Thoracic Surgery clinic or in the inpatient setting based on the surgeon's expertise who need to undergo an elective esophagectomy procedure.

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing emergent esophagectomy
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Vulnerable Populations

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Esophagectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ankit Bharat, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankit Bharat, MD

CONTACT

312-926-7628; ankit.bharat@northwestern.edu

Sara Krezalek, BSN

CONTACT

312-926-7577; sara.krezalek@nm.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 18, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): May 25, 2028
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)