Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
endoscopic suturing of the anastomotic leak
UKSH
Kiel, Schleswig-Holstein, Germany
Safety
Endpoint to be recorded during hospital stay: Composite serious adverse event endpoint for 30 days after the diagnosis of anastomotic leakage including: * Death * Injury to vessels through the suture device, leading to bleeding or thrombosis * Cardiac tamponade, arrhythmia * Pneumothorax * Bleeding requiring transfusion * possible medium-term complications such as new mediastinal abscess
Time frame: 2 years
Technical feasibility
Technical success of the anastomotic closure
Time frame: 2 years
Time to healing of the anastomotic leak
Scored during the hospital stay until 6 months after the original operation. Patients who die or undergo complete resection of the organ (e. g. esophagectomy with cervical fistula) are scored as "nevel healed" - i.e. censored events. Efficacy statistics need to use local historic controls and literature data. Statistical analysis will be performed using the LogRank test.
Time frame: 2 years
Long term safety
Long term safety * Anastomotic stenosis, as assessed by endoscopy * Clinically apparent functional problems (e.g. dysphagia, incontinence)
Time frame: 6 months after diagnosis of anastomotic leakage
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