The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:

‣ pre (ChT-)RT staging: cT1/T2/T3 N0/N+;

⁃ pre STL staging: rcT1/cT2/ Selected cT3 cT4a (extension to thyroid cartilage and/or prelaryngeal tissues) N0/N+ (clinically and radiologically).

• Indication for STL surgery (no pharyngeal mucosal resection);

• Functional total laryngectomies after radical (chemo-)radiotherapy treatment;

• Age \> 18 years;

• Signature of informed consent and ability to complete in-office questionnaires.

Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Raul Pellini, Doctor
raul.pellini@ifo.it
06-52664484
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2025-09-21
Participants
Target number of participants: 102
Treatments
Salvage total laryngectomy STL primary suture
Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing.The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)31. It would be preferable for all centers to use a homogeneous pharyngeal suture technique, such as the T-shaped with Connell suture.
Salvage total laryngectomy STL primary suture + onlay flap
Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing, but in the patients of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. Reconstruction with the onlay technique can be performed using a pedicled pectoralis major myofascial flap or anterolateral thigh myofascial free flap at the surgeon's discretion (pharyngeal suture unchanged). The flap will be positioned with an onlay technique to reinforce the pharyngeal suture and in turn sutured to the prevertebral fascia or residual surrounding tissues.
Related Therapeutic Areas
Sponsors
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov