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Clinical Trials/NCT01551433
NCT01551433CompletedNot Applicable

A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy

Memorial Sloan Kettering Cancer Center1 site in 1 country166 target enrollmentStarted: February 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
166
Locations
1
Primary Endpoint
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.

Study Overview

Brief Summary

The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
  • > or = to 21 years of age

Exclusion Criteria

  • Patients who are not candidates for an esophagectomy as determined by the treating surgeon

Outcomes

Primary Outcomes

association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.

Time Frame: 2 years

The primary objective of this observational study is to determine whether in patients undergoing Ivor Lewis esophagectomy, low levels of tissue oxygenation at the anastomotic site are associated with increased risk of anastomotic leak (AL).

Secondary Outcomes

  • To correlate various demographic(2 years)
  • To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture(2 years)
  • To correlate clinical variables(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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