Clinical trial NCT05950438: Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
Official title: A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagectomy
Keywords: Robotic Transhiatal
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of Participants with Anastomotic Leak
timeFrame: During first 3 months postop
measure: Number of Participants with Esophageal Stricture
timeFrame: During first 3 months postop
measure: Number of Participants with Pneumonia
timeFrame: During first 3 months postop
measure: Number of Participants Requiring Ventilation >48 Hours
timeFrame: During first 3 months postop
measure: Number of Participants with Empyema
timeFrame: During first 3 months postop
measure: Number of Participants with Pulmonary Embolism
timeFrame: During first 3 months postop
measure: Number of Participants with Deep Venous Thrombosis
timeFrame: During first 3 months postop
measure: Number of Participants with Gastric Outlet Obstruction
timeFrame: During first 3 months postop
measure: Number of Participants with Stroke
timeFrame: During first 3 months postop
measure: Number of Participants with Atrial Fibrillation
timeFrame: During first 3 months postop
measure: Number of Participants with Vocal Cord Paralysis
timeFrame: During first 3 months postop
measure: Number of Participants with Myocardial Infarction
timeFrame: During first 3 months postop
measure: Number of Participants with Chylothorax
timeFrame: During first 3 months postop
measure: Number of Participants with Acute Renal Injury
timeFrame: During first 3 months postop
measure: Number of Participants with Wound Infections
timeFrame: During first 3 months postop
measure: Rates of Re-operation
timeFrame: During first 3 months postop
measure: Rates of Re-Admission
timeFrame: During first 3 months postop
measure: Number of Participants with Intensive Care Unit (ICU) Stay
timeFrame: During first 3 months postop
measure: Rates of Length of Hospital Stay
timeFrame: Postoperative
measure: Rates of 30-day Survival
timeFrame: Postoperative
measure: Rates of 90-day Survival Rates
timeFrame: Postoperative
Secondary outcomes:
measure: Operative Time of Surgery
timeFrame: Intraoperative
measure: Rates of Blood Loss
timeFrame: Intraoperative
measure: Number of Participants with Conversion Rates to Open Esophagectomy
timeFrame: Intraoperative
measure: Number of Participants with Lymph nodes in the Final Specimen
timeFrame: Intraoperative
measure: Number of Participants with Proximal and Distal Margins
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Ankit Bharat, MD
role: PRINCIPAL_INVESTIGATOR
References: