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