endoscopic suturing

endoscopic suturing of the anastomotic leak

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

Technical success of the anastomotic closure

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.