NCT06308016

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.

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Laryngeal Cancer

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: Italy