RecruitingNCT06308016

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)


Sponsor

Regina Elena Cancer Institute

Enrollment

500 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study looks at what factors increase the risk of developing a pharyngocutaneous fistula — a hole that can form between the throat and the skin after total laryngectomy (complete removal of the voice box). Researchers want to build a scoring tool that surgeons can use before the operation to identify high-risk patients. **You may be eligible if...** - You are scheduled for total laryngectomy (complete voice box removal) - Your surgery involves a laryngeal (voice box) tumor that is new, came back after prior surgery within the larynx, or came back after radiation or chemoradiation treatment - Your case involves a non-functioning voice box caused by radiation treatment **You may NOT be eligible if...** - Your surgery requires the use of a tissue flap (a piece of skin or muscle moved from another part of the body to help close the wound) - You have previously had surgery on the throat area above the voice box (hypopharynx or oropharynx) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

"Regina Elena" National Cancer Institute

Rome, Italy

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NCT06308016


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