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Recruiting NCT05950438

Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

— Observational Esophagectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esophagectomy.
Who it may be relevant to
Registry conditions: Esophagectomy. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Number of Participants with Anastomotic Leak [Time frame: During first 3 months postop]
  • Number of Participants with Esophageal Stricture [Time frame: During first 3 months postop]
  • Number of Participants with Pneumonia [Time frame: During first 3 months postop]
  • Number of Participants Requiring Ventilation >48 Hours [Time frame: During first 3 months postop]
  • Number of Participants with Empyema [Time frame: During first 3 months postop]
  • Number of Participants with Pulmonary Embolism [Time frame: During first 3 months postop]
  • Number of Participants with Deep Venous Thrombosis [Time frame: During first 3 months postop]
  • Number of Participants with Gastric Outlet Obstruction [Time frame: During first 3 months postop]
  • Number of Participants with Stroke [Time frame: During first 3 months postop]
  • Number of Participants with Atrial Fibrillation [Time frame: During first 3 months postop]
Secondary outcome measures (5)
  • Operative Time of Surgery [Time frame: Intraoperative]
  • Rates of Blood Loss [Time frame: Intraoperative]
  • Number of Participants with Conversion Rates to Open Esophagectomy [Time frame: Intraoperative]
  • Number of Participants with Lymph nodes in the Final Specimen [Time frame: Intraoperative]
  • Number of Participants with Proximal and Distal Margins [Time frame: Intraoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT05950438 · STU00219267

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗