The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
NCT06287034 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 102
Last updated 2024-02-29
Summary
Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)
Conditions
- Larynx Carcinoma
Interventions
- PROCEDURE
-
Primary suture
The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)
Sponsors & Collaborators
-
Regina Elena Cancer Institute
lead OTHER
Principal Investigators
-
Raul Pellini, Doctor · IRCCS "Regina Elena" National Cancer Institute
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-21
- Primary Completion
- 2025-03-21
- Completion
- 2025-09-21
Countries
- Italy
Study Locations
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