Clinical trial · Observational
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.
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)
NCT06308016CI-TRIAL-00075004unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identification of risk factors
- timeFrame
- 12 months
- description
- The primary objective of the project is the identification of pre-operative risk factors
Secondary outcomes (1)
- measure
- Stratify patients
- timeFrame
- 12 months
- description
- The secondary objective is to construct a score to stratify patients according to the risk of developing PCF
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.