The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
Regina Elena Cancer Institute
102 participants
Mar 21, 2023
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria7
- Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:
- 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;
- Age > 18 years;
- Signature of informed consent and ability to complete in-office questionnaires.
Exclusion Criteria3
- 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).
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Interventions
The 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)
Locations(1)
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NCT06287034