Clinical Trial: Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Neck Flexion on Post-operative Esophagogastric Anastomotic Leakage After Minimally Invasive Esophagectomy: a Single-center Randomized Controlled Trial

Brief Summary: Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC. Gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension. In this study, the investigators attempt to adopt the maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing the incidence of CAL.

Detailed Summary: After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant. The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon. The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Current Primary Outcome: Incidence of post-operative cervical esophagogastric anastomotic leakage [ Time Frame: From the day of operation to hospital discharge (an expected average of 2 weeks) ]

The post-operative cervical esophagogastric anastomotic leakage is defined as a radiological defect at the anastomotic site, or leakage of swallowed fluid (saliva, gastric juice or food residue) out of the drain site or cervical wound.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Dates:
Date Received: April 12, 2015
Date Started: January 2014
Date Completion: December 2016
Last Updated: April 15, 2015
Last Verified: April 2015