Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)
pre (ChT-)RT staging: cT1/T2/T3 N0/N+;
pre STL staging: rcT1/cT2/ Selected cT3 cT4a (extension to thyroid cartilage and/or prelaryngeal tissues) N0/N+ (clinically and radiologically).
Indication for STL surgery (no pharyngeal mucosal resection);
Functional total laryngectomies after radical (chemo-)radiotherapy treatment;
STL extended to the pharynx and/or total pharyngeal laryngectomies;
Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension;
Previous open organ preservation surgery (OPHL).
Patients suffering from recurrence/persistence of laryngeal SCC following exclusive RT treatment or concomitant RT/ChT without extension to the pharynx (rcT1/T2/T3 selected rcT4a N0/N+) who will have to undergo STL and who will meet the following criteria. Patients undergoing extensive laryngectomies or with disease with even partial involvement of the pharyngeal mucosa (pyriform sinus, posterior wall of the pharynx) will not be included.
Cohort
Prospective
Primary suture
Procedure/SurgeryThe primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)
questionnaires for evaluation of the quality of life
Questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire).
Identification of risk factors
Identification of risk factors related to the formation of pharyngocutaneous fistulas after salvage total laryngectomy
Evaluation of swallowing function
Evaluation of swallowing function assessed using the SOAL questionnaire
Evaluation of vocal rehabilitation
Evaluation of vocal rehabilitation using the SECEL questionnaire
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