Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
|ClinicalTrials.gov Identifier: NCT01551433|
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Device: wireless pulse oximeter (Wipox)|
|Study Type :||Observational|
|Actual Enrollment :||166 participants|
|Official Title:||A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy|
|Study Start Date :||February 2012|
|Primary Completion Date :||August 2016|
|Study Completion Date :||August 2016|
Pts scheduled for Ivor Lewis esophagectomy
During the operation, once the gastric conduit has been mobilized and positioned, and once the anastomotic site has been identified by the surgeon, the assigned RSA will provide the Wipox instrument to the fellow (the primary surgeon will be blinded to the result) who will then obtain one measurement from the anastomotic site.
Device: wireless pulse oximeter (Wipox)
In addition to the one Wipox measurement at the planned anastomotic site, the RSA will collect the systemic pulse oximeter reading, blood pressure, and heart rate at the time of the Wipox measurement. These measurements will be obtained as both internal controls of the accuracy of the Wipox (matching the Wipox pulse rate with the patient's), as well as additional variables to control for when assessing factors which might contribute to oxygen saturation at the anastomotic site. Pre-operative demographic information will be collected. This will include age, sex, any co-morbidities (cardiac, diabetes, respiratory), and use of pre-operative chemotherapy or chemo-radiotherapy.
- 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).
- To correlate various demographic [ Time Frame: 2 years ](age, co-morbidities, smoking history) and clinical variables (pre-operative therapy, intra-operative blood pressure and systemic oxygen saturation) with tissue oxygenation at the anastomotic site. Spearman rank correlation (for continuous variables) and Wilcoxon rank sum test (for categorical variables) will be used to test these associations.
- To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture [ Time Frame: 2 years ]the association between anastomotic site tissue oxygenation and the incidence of post-discharge stricture observed during the 6 months following surgery will be assessed using Wilcoxon rank sum test (with O2 levels on a continuous scale) and Fisher exact test.
- To correlate clinical variables [ Time Frame: 2 years ](age, co-morbidities, smoking history) and clinical variables (pre-operative therapy, intra-operative blood pressure and systemic oxygen saturation) with tissue oxygenation at the anastomotic site. Spearman rank correlation (for continuous variables) and Wilcoxon rank sum test (for categorical variables) will be used to test these associations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551433
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Prasad Adusumilli, MD||Memorial Sloan Kettering Cancer Center|