Purpose Tracheoesophageal speech (TES) with a voice prosthesis (VP) is considered standard care in many countries for voice rehabilitation after total laryngectomy. Until recently, VPs were not available in China, and therefore patients had to use other communication methods. The aim of this study was to evaluate the feasibility of secondary tracheoesophageal puncture (TEP) as well as the effectiveness of TES as a method of voice rehabilitation in Chinese-speaking individuals living in China. Materials and Methods This clinical study was designed as a multicenter prospective single arm study. Thirty-six laryngectomy patients were enrolled and underwent a secondary tracheoesophageal puncture with placement of a Provox Vega. Voice assessments (clinician rated, objective assessment, and patient reported) were performed prior to VP placement and after 24 weeks, and VPs were changed every 3 months. Voice rehabilitation success and complications were recorded. Clinical Trials.gov Identifier: NCT05482815. Results There was a statistically significant improvement in clinician rated perceptual speech assessment (fluency, speed, pitch, intelligibility) at 24 weeks after TEP compared to baseline scores prior to placement of a VP. Sound intensity was significantly higher after TEP compared to pre-TEP, however, no significant change in maximum phonation time was observed. Patient reported voice handicap index was significantly lower after TEP compared to baseline. At the end of the study, 81% of the participants (29/36) were considered to have achieved an effective voice. Conclusion TEP is a feasible and an effective communication option post-laryngectomy for patients in China.
