Evaluating the risk of complications after total laryngectomy for laryngeal cancer
Study of the Risk of Pharyngocutaneous Fistula (PCF) in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification (Fistula-score)
This study is trying to find out which factors might put people at higher risk for complications after surgery for laryngeal cancer, so doctors can better predict and manage those risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06308016 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes a cohort of approximately 500 patients with laryngeal cancer who underwent total laryngectomy. The aim is to evaluate various pre-operative risk factors to develop a scoring system that can stratify patients into low and high risk for developing pharyngocutaneous fistula (PCF) post-surgery. By identifying these risks, the study seeks to enhance surgical outcomes and minimize complications associated with the procedure. Data will be collected retrospectively from multiple centers to ensure a comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates include patients with laryngeal neoplasms eligible for total laryngectomy without prior extensive surgical interventions.
Not a fit: Patients who have undergone previous extensive surgeries or those requiring complex reconstructive techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of surgical complications for patients undergoing total laryngectomy.
How similar studies have performed: Other studies have shown success in developing risk stratification tools for surgical complications, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Raul Pellini, Doctor — IRCCS "Regina Elena" National Cancer Institute
- Study coordinator: Raul Pellini, Doctor
- Email: raul.pellini@ifo.it
- Phone: 06 5266 6765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.