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.

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Laryngeal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06308016

25/IRE/23

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients undergoing LT surgery with direct closure of the pharynx in case of:

• naïve 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.