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NCT Number: NCT05950438

Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants with Anastomotic Leak

    Time frame: During first 3 months postop

    Postoperative Complication

  2. Number of Participants with Esophageal Stricture

    Time frame: During first 3 months postop

    Postoperative Complication

  3. Number of Participants with Pneumonia

    Time frame: During first 3 months postop

    Postoperative Complication

  4. Number of Participants Requiring Ventilation >48 Hours

    Time frame: During first 3 months postop

    Postoperative Complication

  5. Number of Participants with Empyema

    Time frame: During first 3 months postop

    Postoperative Complication

  6. Number of Participants with Pulmonary Embolism

    Time frame: During first 3 months postop

    Postoperative Complication

  7. Number of Participants with Deep Venous Thrombosis

    Time frame: During first 3 months postop

    Postoperative Complication

  8. Number of Participants with Gastric Outlet Obstruction

    Time frame: During first 3 months postop

    Postoperative Complication

  9. Number of Participants with Stroke

    Time frame: During first 3 months postop

    Postoperative Complication

  10. Number of Participants with Atrial Fibrillation

    Time frame: During first 3 months postop

    Postoperative Complication

  11. Number of Participants with Vocal Cord Paralysis

    Time frame: During first 3 months postop

    Postoperative Complication

  12. Number of Participants with Myocardial Infarction

    Time frame: During first 3 months postop

    Postoperative Complication

  13. Number of Participants with Chylothorax

    Time frame: During first 3 months postop

    Postoperative Complication

  14. Number of Participants with Acute Renal Injury

    Time frame: During first 3 months postop

    Postoperative Complication

  15. Number of Participants with Wound Infections

    Time frame: During first 3 months postop

    Postoperative Complication

  16. Rates of Re-operation

    Time frame: During first 3 months postop

    Postoperative Complication

  17. Rates of Re-Admission

    Time frame: During first 3 months postop

    Postoperative Complication

  18. Number of Participants with Intensive Care Unit (ICU) Stay

    Time frame: During first 3 months postop

    Postoperative Complication

  19. Rates of Length of Hospital Stay

    Time frame: Postoperative

    Postoperative Complication

  20. Rates of 30-day Survival

    Time frame: Postoperative

    Postoperative Complication

  21. Rates of 90-day Survival Rates

    Time frame: Postoperative

    Postoperative Complication

Secondary outcomes

  1. Operative Time of Surgery

    Time frame: Intraoperative

    Length of Surgery

  2. Rates of Blood Loss

    Time frame: Intraoperative

    Did the Participant Lose Any Blood During the Surgery

  3. Number of Participants with Conversion Rates to Open Esophagectomy

    Time frame: Intraoperative

  4. Number of Participants with Lymph nodes in the Final Specimen

    Time frame: Intraoperative

    Pathological Variables

  5. Number of Participants with Proximal and Distal Margins

    Time frame: Intraoperative

    Pathological Variables

Study contacts

Contact information is provided by the study sponsor or research team.

Ankit Bharat, MD

CONTACT

[email protected]

312-926-7628

Sara Krezalek, BSN

CONTACT

[email protected]

312-926-7577

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 18, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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