Classical versus wire-guided balloon catheter puncture technique for voice prosthesis insertion: a randomized open-label clinical trial

Abstract

Background: Tracheoesophageal puncture with voice prosthesis insertion is recognized as an effective and reliable method for voice restoration after total laryngectomy that may be performed as a primary, at the time of laryngectomy, or a secondary procedure. The same surgical procedure of voice prosthesis insertion in secondary time that was introduced by Singer and Blom decades ago, is still in use today. The use of this technique has a high success rate of vocal rehabilitation with some limitations and an acceptable complication rate. Tobed et al. In order to remove its complications and limitations, have developed a minimally invasive method for voice prosthesis insertion performed with a wire-guided balloon catheter puncture. Objective: The aim of this study is to register and compare the post-intervention outcomes in patients rehabilitated with wire-guided balloon catheter puncture technique compared to those who received the classic procedure. Design: This is a prospective, randomized, open-label and controlled clinical trial which will be carried out in Hospital Universitari Doctor Josep Trueta from February 2020 until October 2023. Methods: The population of this study will be 18 years or older people diagnosed with locally advanced larynx carcinoma that have received a total laryngectomy for its treatment. A total of 54 patients, 27 per group, will be needed for the study. They will be recruited using a consecutive non-probabilistic method, and they will be randomly

assigned with a ratio 1:1 to receive the classic technique (control group) or the wire- guided balloon catheter puncture technique (intervention group)