esophageal cancer esophageal carcinoma
Conditions
Interventions
Protocol oral intake: From day 1-6 posteropatively, patients are only allowed
to take sips of water. On day 7 fluids and semisolid food is allowed. In
between day 8 and 10 normal oral intake is cont
*In the terminalized semimechanical side-to-side suture technique,
once the cervical esophagus has been transected and the stomach pulled up to
the neck, a small incision is made at the top of the g
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Esophageal resection with stomach tube reconstruction for esophageal carcinoma * Signed informed consent * Availability for 1 year follow-up in the Erasmus Medical Center * Age over 18 year
Exclusion criteria
Exclusion criteria: * Other forms of esophageal reconstruction than a stomach tube. * Classification of American Society of Anaesthesiologists over or equal to 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: clinical anastomotic leakage defined by neck wound infection and loss of saliva and/or fluids through the wound site, signs of mediastinitis or abcess intrathoracic or leakage confirmed by radiological examination (endoscopy or CT with contrast fluids) after clinical suspicion (i.e. leucocytosis, fever, pain), all within 30 days after operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints: anastomotic stricture within one year, number of dilations within one year, dysphagia score (table 1, score by Sugahara), quality of life measured by EORTC QLQ C-30 and OES-18 questionnaires preoperative and at 3, 6, 9 and 12 months after surgery. | — |
Countries
Netherlands
Outcome results
None listed