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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.

Laryngeal Cancer Clinical Trial

Official title:
Study of the Risk of Pharyngocutaneous Fistula (PCF) in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification (Fistula-score)

Clinical Trial 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.

Clinical Trial Description

Evaluate the relative weight of each factor pre-operative risk, in order to build a score (fistula-score) to be able to stratify before surgery surgical total laryngectomy patients in low-risk and high-risk PCF pharyngocutaneous fistula. Analyze and process data relating to a total of approximately 500 patients underwent, consecutively, total laryngectomy for malignant neoplasm of the larynx The results obtained from the present study will allow patients to be stratified into low and high risk for PCF to undergo total laryngectomy, so as to reduce this surgical complication ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06308016
Study type Observational
Source Regina Elena Cancer Institute
Contact Raul Pellini, Doctor
Phone 06 5266 6765
Email raul.pellini@ifo.it
Status Recruiting
Phase
Start date December 1, 2023
Completion date December 1, 2024
View Details
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