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Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05950438
Enrollment
120
Registered
2023-07-18
Start date
2023-07-11
Completion date
2028-05-25
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagectomy

Keywords

Robotic Transhiatal

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.

Interventions

PROCEDUREEsophagectomy

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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Anastomotic LeakDuring first 3 months postopPostoperative Complication
Number of Participants with Esophageal StrictureDuring first 3 months postopPostoperative Complication
Number of Participants with PneumoniaDuring first 3 months postopPostoperative Complication
Number of Participants Requiring Ventilation >48 HoursDuring first 3 months postopPostoperative Complication
Number of Participants with EmpyemaDuring first 3 months postopPostoperative Complication
Number of Participants with Pulmonary EmbolismDuring first 3 months postopPostoperative Complication
Number of Participants with Deep Venous ThrombosisDuring first 3 months postopPostoperative Complication
Number of Participants with Gastric Outlet ObstructionDuring first 3 months postopPostoperative Complication
Number of Participants with StrokeDuring first 3 months postopPostoperative Complication
Number of Participants with Atrial FibrillationDuring first 3 months postopPostoperative Complication
Number of Participants with Vocal Cord ParalysisDuring first 3 months postopPostoperative Complication
Number of Participants with Myocardial InfarctionDuring first 3 months postopPostoperative Complication
Number of Participants with ChylothoraxDuring first 3 months postopPostoperative Complication
Number of Participants with Acute Renal InjuryDuring first 3 months postopPostoperative Complication
Number of Participants with Wound InfectionsDuring first 3 months postopPostoperative Complication
Rates of Re-operationDuring first 3 months postopPostoperative Complication
Rates of Re-AdmissionDuring first 3 months postopPostoperative Complication
Number of Participants with Intensive Care Unit (ICU) StayDuring first 3 months postopPostoperative Complication
Rates of Length of Hospital StayPostoperativePostoperative Complication
Rates of 30-day SurvivalPostoperativePostoperative Complication
Rates of 90-day Survival RatesPostoperativePostoperative Complication

Secondary

MeasureTime frameDescription
Operative Time of SurgeryIntraoperativeLength of Surgery
Rates of Blood LossIntraoperativeDid the Participant Lose Any Blood During the Surgery
Number of Participants with Conversion Rates to Open EsophagectomyIntraoperative
Number of Participants with Lymph nodes in the Final SpecimenIntraoperativePathological Variables
Number of Participants with Proximal and Distal MarginsIntraoperativePathological Variables

Countries

United States

Contacts

CONTACTAnkit Bharat, MD
ankit.bharat@northwestern.edu312-926-7628
CONTACTSara Krezalek, BSN
sara.krezalek@nm.org312-926-7577
PRINCIPAL_INVESTIGATORAnkit Bharat, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026