Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Study Overview
=================
Brief Summary
-----------------
Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis. Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.

Detailed Description
-----------------
The transfer of muscle parts is one of the main reconstruction techniques used in plastic surgery. Transverse rectus abdominis myocutaneous (TRAM) flap transfers are very considered due to high quality results, wide application in many cases, and small number of reviews in long term. Beegle, in 1991 published a new technique of using TRAM supercharged in which microsurgical anastomosis are used between TRAM's unipedicled gastroepiploic deep artery and veins and thoracic branches and vessels, such as axillary and thoracodorsal vessels. Looking for recover tissue blood perfusion and decrease morbidity rates associated with anastomosis ischemia, some studies showed large intestine or jejunum interposition plus an additional blood supply through venous and arterial anastomosis - colon or jejunum supercharged is effective. The isoperistaltic supercharged colon interposition was a good option to rebuild big esophagus parts in which stomach was not available. Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. This is a single-institution, randomized clinical trial with participants recruited in the digestive system surgery clinic, at the Instituto do Câncer do Estado de São Paulo (ICESP). Patients will be randomized to conventional esophagectomy or TRAM supercharged esophagectomy, and researchers will evaluate post-operatory complications in both groups.

Official Title
-----------------
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Conditions
-----------------
Esophagus Cancer, Carcinoma Esophagus

Intervention / Treatment
-----------------
* Procedure: Supercharged TRAM esophagectomy
* Procedure: Conventional Esophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of esophageal malignancy cancer; Ability to understand and collaborate during treatment; Exclusion Criteria: Previous gastrectomy; Previous abdominal surgery with risk of altering stomach vascularization; Previous head and neck surgery with risk of alteration of cervical vessels.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Esophagectomy group<br>Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty. | Procedure: Conventional Esophagectomy<br>* Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.<br>|
| Experimental: Supercharged TRAM esophagectomy group<br>Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty. | Procedure: Supercharged TRAM esophagectomy<br>* Esophagectomy, immediately followed by supercharged esophagogastroplasty. Use the transverse rectus abdominis myocutaneous (TRAM) flap transfers to surgically create a new anastomosis in the left gastroepiploic vessels.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and number of post-operatory complications | surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization | Until 1 year after Surgery | 
| Mortality | Patients who and when died | Until 1 year after surgery after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days in intensive care unit | Number of days patient will stay at intensive care unit | From the surgery day until the date patient leave intensive care unit | 
| Hospitalization period | Number of days patient will stay in hospital after surgery | From the surgery day until the date patient leave hospital | 
| Need of vasoactive drugs | If patient use vasoactive drugs drugs hospitalization | From the surgery day until the date patient leave hospital | 
| Blood transfusion need | If patients need blood transfusion during hospitalization | From the surgery day until the date patient leave hospital | 
| Drain use time | How long patient use drain | From the surgery day until the date patient took off drain | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagectomy, Esophagogastroplasty, Supercharged