Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryn… (NCT06308016) | Clinical Trial Compass
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Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification.
Italy500 participantsStarted 2023-12-01
Plain-language summary
Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria.
Who can participate
SexALL
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Inclusion Criteria:
Patients undergoing LT surgery with direct closure of the pharynx in case of:
* naĂŻve laryngeal neoplasm (cT1-T3 and cT4a without extension to the esophagus or hypopharynx or oropharynx);
* recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (CO2 laser limited within the larynx or OPHL);
* recurrence of laryngeal neoplasm after RT or Ch-RT treatment;
* lack of functionality of the larynx induced by (Ch-)RT treatment;
* Availability of data according to the assessments that will have to be made, including a FU period of 2 months.
Exclusion Criteria:
* Use of flap, pedicled / free, on-lay / in-lay at the same time as LT surgery. Patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.