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.

NCT06308016 | Recruiting

• 1 other identifier: 25/IRE/23
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of risk factors

  The primary objective of the project is the identification of pre-operative risk factors

  12 months

Secondary Outcomes (1)

• Stratify patients

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the present study, data relating to patients who, in a manner, will be analyzed retrospectively consecutive, I meet the following criteria. All patients underwent procedures and/or diagnostic-therapeutic procedures, as well as tests and assessments as required by guidelines and/or conventional clinical management

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Raul Pellini, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raul Pellini, Doctor

CONTACT

06 5266 6765; raul.pellini@ifo.it

Francesco Mazzola, Doctor

CONTACT

06 5266 4485; francesco.mazzola@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)