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
Inclusion Criteria6
- 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 Criteria1
- 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06308016
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