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ID06287034

The Role of the FreePedunculated Flap in Total Laryngectomy After Chemo-Radiotherapy Failure for Laryngeal Carcinoma Impact on the Risk of Pharyngocutaneous Fistula PCF

Led by Regina Elena Cancer Institute

Updated on 2026-06-05

102

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1

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130 weeks

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What This Trial Is About

Researchers are evaluating the risk of developing pharyngocutaneous fistula PCF after salvage total laryngectomy STL in patients with laryngeal carcinoma who had recurrence or persistence of disease following radiotherapy or chemo-radiotherapy. This multicenter, prospective, randomized study compares two groups one receiving STL with primary suture alone, and another receiving STL with primary suture plus reinforcement using a free or pedunculated flap via the onlay technique.



The study aims to understand how flap reinforcement impacts PCF risk and post-surgical recovery. Participants are randomized into two groups one undergoes STL with primary suture using various suture techniques chosen at the surgeons discretion, such as vertical, horizontal, or T-shaped closure. The second group receives the same surgery plus the addition of a covering flap positioned with the onlay technique, using either a pedicled pectoralis major myofascial flap or an anterolateral thigh free flap. The flap is sutured to reinforce the pharyngeal closure. Both groups undergo surgery followed by post-operative assessments. After surgery, participants complete questionnaires at 4 months to assess quality of life related to vocal and swallowing rehabilitation using voice prosthesis or esophageal voice SECEL and SOAL questionnaires. Researchers collect demographic, clinical, surgical, and pathological data, includin

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