Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto do Cancer do Estado de São Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of esophageal malignancy cancer;
Ability to understand and collaborate during treatment;
Disqualifiers
Previous gastrectomy;
Previous abdominal surgery with risk of altering stomach vascularization;
Previous head and neck surgery with risk of alteration of cervical vessels.
Trial design
Design model
Parallel
Treatments tested in this trial
Supercharged TRAM esophagectomy
Procedure/SurgeryEsophagectomy, 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.
Conventional Esophagectomy
Procedure/SurgeryEsophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Conventional Esophagectomy groupActive comparator 1 intervention
Group B: Supercharged TRAM esophagectomy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence and number of post-operatory complications
surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization
Time frame
Until 1 year after Surgery2
Mortality
Patients who and when died
Time frame
Until 1 year after surgery after surgerySecondary outcomes
1
Days in intensive care unit
Number of days patient will stay at intensive care unit
Time frame
From the surgery day until the date patient leave intensive care unit2
Hospitalization period
Number of days patient will stay in hospital after surgery
Time frame
From the surgery day until the date patient leave hospital3
Need of vasoactive drugs
If patient use vasoactive drugs drugs hospitalization
Time frame
From the surgery day until the date patient leave hospital4
Blood transfusion need
If patients need blood transfusion during hospitalization
Time frame
From the surgery day until the date patient leave hospitalSponsors and contacts
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Source ClinicalTrials.gov