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.

Recruiting

• Conditions: Laryngeal Cancer

• Registration Number: NCT06308016
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of risk factors	12 months	The primary objective of the project is the identification of pre-operative risk factors

Secondary Outcome Measures

Name	Time	Method
Stratify patients	12 months	The secondary objective is to construct a score to stratify patients according to the risk of developing PCF

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy