Comparison of voice quality and functionality between muscle and fasciocutaneous flaps used for pharyngeal reconstruction after a total laryngectomy: a multicentre, randomized, clinical trial

Abstract

BACKGROUND: Larynx cancer is the most frequent one in head and neck cancer and a huge part of these, especially the supraglottic ones, are diagnosed at locally advanced stages. In these cases, surgery by means of total laryngectomy followed by adjuvant treatment has shown to have better results in local disease control and survival than the organ preservation chemoradiotherapy protocols promoted from the 1980s onwards. In addition, in many times,

total laryngectomy needs to be followed by a partial pharyngectomy in order to ensure disease- free surgical margins. In these cases, the reconstruction of the pharynx using a flap, either

muscular or fasciocutaneous, takes on great importance because of the relevance of the pharynx in the rehabilitation of the patient. Even though, no experimental study has ever been designed to compare the quality and functionality of the voice produced by the patient according to the type of flap that has been used to reconstruct the pharynx. Since we consider it is of vital importance to be able to offer the best quality of life to all patients operated on by oncological surgery, we believe that it should be studied which reconstruction techniques are capable of achieving a better voice in the laryngectomised patients, as the voice is a crucial element in our lives and its loss has a great psychological impact and a huge influence on the quality of life. OBJECTIVE: The aim of this study is to prove that pharynx reconstruction with a muscular flap after a total laryngectomy produces a better quality and functionality voice than reconstruction with fasciocutaneuous flaps. DESIGN AND SETTING: This is a multicentre, randomized, open-labelled clinical trial performed among five tertiary hospitals of Catalonia. PARTICIPANTS: Subjects of this study will be those newly diagnosed locally advanced larynx or hypopharynx squamous cell carcinoma who are treated with a total laryngectomy and require a pharynx reconstruction. METHODS: 60 patients will be recruited with a consecutive method. Recruitment of patients will last 24 months. They will be assigned randomly to one of the three treatment groups: group A: pharynx wall reconstruction with PMMF (n=30), group B: pharynx wall reconstruction with RFFF (n=15) and group C: pharynx reconstruction with ALT fasciocutaneous flap (n=15). After the intervention there will be a subsequent follow-up for 16 months. The voice quality and functionality will be evaluated with VHI-30 questionnaire during one year after the voice prosthesis placement. ANOVA test and a General Linear Model for repeated measures will be used for statistical analyses of the voice quality and functionality between the two groups of flaps