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RECRUITING
NCT06287034

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)

Sponsor: Regina Elena Cancer Institute

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

102

Start Date

2023-03-21

Completion Date

2027-09-21

Last Updated

2026-06-05

Healthy Volunteers

Not specified

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)

Locations (1)

"Regina Elena" National Cancer Institute

Rome, Rome, Italy