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.

Launched by REGINA ELENA CANCER INSTITUTE · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the risk of a complication called pharyngocutaneous fistula in patients who are undergoing total laryngectomy surgery for laryngeal cancer. A pharyngocutaneous fistula is an abnormal connection that can form between the throat and the skin, which can happen after surgery. The study aims to gather information from different medical centers to understand better who might be at higher risk for this complication and to create a scoring system to help doctors assess these risks before surgery.

To be eligible for this study, you must be someone who is having total laryngectomy surgery for laryngeal cancer. This includes patients with new or recurring laryngeal tumors, as long as the cancer hasn’t spread to nearby areas like the esophagus or hypopharynx. Importantly, the study excludes patients who will have other types of surgeries at the same time. If you participate, you’ll be asked to provide information about your medical history and will be followed up for about two months after your surgery to see how you’re doing. This research is important as it aims to improve safety and outcomes for patients undergoing this type of surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• • 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.