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โ† Trials
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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)

Recruitingn/aAges 18 Years - anyAllRegina Elena Cancer Institute
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment: 1. pre (ChT-)RT staging: cT1/T2/T3 N0/N+; 2. 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 Criteria: * 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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What it tests

  • Primary suture
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Where

1 site
"Regina Elena" National Cancer Institute
Rome, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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