About this trial
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)
Eligibility criteria
Qualifiers
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;
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Primary suture