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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Esophagectomy group | Active Comparator | Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty. |
|
| Supercharged TRAM esophagectomy group | Experimental | Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supercharged TRAM esophagectomy | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flavio Takeda, PhD, MD | Contact | +55 11 999079973 | flavio.takeda@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Flavio Takeda, PhD, MD | Instituto do Cancer do Estado de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de São Paulo (ICESP) | Recruiting | São Paulo | São Paulo | 01246000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Conventional Esophagectomy | Procedure | Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty. |
|
| 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 |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |