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NCT06287034
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)
Conditions: Larynx Carcinoma
Sex: All
Ages: 18 Years – N/A
Enrollment: 102
Sponsor: Regina Elena Cancer Institute
Location: "Regina Elena" National Cancer Institute Rome Rome
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 Criteria
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).
Source: ClinicalTrials.gov (NCT06287034). StuddyBuddy aggregates publicly available trial information.