Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Esophageal Cancer

Treatments: Device: wireless pulse oximeter (Wipox)

Study type: Observational

Funder types: Other

Identifiers

NCT01551433

11-192

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

166 participants in 1 patient group

Pts scheduled for Ivor Lewis esophagectomy

Description:

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.

Treatment:

Device: wireless pulse oximeter (Wipox)