In vitro Experiments with the Triangular Flap Cutter Applied to Functional Tracheoesophageal Shunt for Voice Rehabilitation after Total Laryngectomy

Backgrounds: Since the introduction and practice of functional tracheoesophageal shunt (FTES) for voice rehabilitation after total laryngectomy, patients have often suffered from fistula-related complications such as aspiration, tract stenosis and infection partly as a result of nonstandardized or incorrectly made flap operation. In striving to solve these problems as far as possible, a triangular flap cutter (TFC) was developed to perform the flap operation. Methods: Flap operations were performed using a TFC on 10 tracheoesophageal models (pigs) and 10 fresh esophageal models (esophageal cancer patients, with their informed consent) and incision parameters and incision effects were detected. Results: Perfect triangular flaps were achieved in 18 out of 20 cases using the TFC with minimal peripheral tissue injury (average time, 2–3 min). Of the 2 unsuccessful cases, 1 case exhibited insertion failure and the other experienced flap creation failure due to clinical contraindication for TFC use and insufficient operational skills, respectively. Conclusions: The TFC is a new device, which offers the unique advantage of precise incision for the creation of a flap, with the potential to resolve fistula-related problems and improve operation efficiency.

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