Instituto do Cancer do Estado de São Paulo (ICESP)
São Paulo, 01246000, Brazil
Location status: Recruiting
Location contact
Flavio Takeda, MD
CONTACT
Flavio Takeda, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05954702
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
São Paulo, 01246000, Brazil
Location status: Recruiting
Flavio Takeda, MD
CONTACT
Flavio Takeda, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Time frame: Until 1 year after Surgery
surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization
Time frame: Until 1 year after surgery after surgery
Patients who and when died
Time frame: From the surgery day until the date patient leave intensive care unit
Number of days patient will stay at intensive care unit
Time frame: From the surgery day until the date patient leave hospital
Number of days patient will stay in hospital after surgery
Time frame: From the surgery day until the date patient leave hospital
If patient use vasoactive drugs drugs hospitalization
Time frame: From the surgery day until the date patient leave hospital
If patients need blood transfusion during hospitalization
Time frame: From the surgery day until the date patient took off drain
How long patient use drain
Contact information is provided by the study sponsor or research team.
Instituto do Cancer do Estado de São Paulo
Other
Acronym: Supercharged
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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