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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287034 on ClinicalTrials.gov