Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287034
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-01-12
Brief Title:
The Role of the FreePedunculated Flap in Total Laryngectomy After Chemo-Radiotherapy Failure for Laryngeal Carcinoma Impact on the Risk of Pharyngocutaneous Fistula PCF
Sponsor:
Regina Elena Cancer Institute
Organization:
Regina Elena Cancer Institute
Study Overview
Official Title:
The Role of the FreePedunculated Flap in Total Laryngectomy After Chemo-Radiotherapy Failure for Laryngeal Carcinoma Impact on the Risk of Pharyngocutaneous Fistula PCF
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients once eligibility has been verified will then be randomized 11 to one of the following groups Gruop 1 STL primary suture Group 2 STL primary suture onlay flap Patients in both groups will then undergo surgery STL with primary suture in those of the second group in addition the positioning of a freepedunculated covering flap will also be carried out with the onlay technique 4 months after surgery questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice SECEL questionnaire and swallowing rehabilitation SOAL questionnaire Demographic and preoperative data will be collected data relating to pre-chemo-radiotherapy and pre-STL clinical staging as well as the interval in days between the end of chemo-radiotherapy and surgery perioperative data type of eventual unilateral or bilateral laterocervical lymph node emptying the type of pharyngotomy suture the type of flap possibly used the packaging of the tracheoesophageal fistula for positioning the voice prosthesis the definitive histological examination
The patient must undergo a radiological examination for loco-regional and distant staging before the STL CT or MRI and a biopsy demonstrating the recurrencepersistence of the disease
The patient must undergo a radiological examination for loco-regional and distant staging before the STL CT or MRI and a biopsy demonstrating the recurrencepersistence of the disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None