NCT07287865

Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Salvage total laryngectomy (TL) and total pharyngolaryngectomy (TPL) are the gold standard for most recurrent laryngeal and hypopharyngeal tumors as well as in patients with contraindication for chemoradiotherapy (CRT). Free or pedicled flaps are the two mandatory options for pharyngeal reconstruction after TPL, while remain an optional indication to protect the neopharynx after TL. The most common complication after TL or TPL is pharyngocutaneous fistula (PCF), with an incidence ranging from 3% to 65%, according to the surgical defect and type of reconstruction. The etiology of PCF is multifactorial and the most important risk factors are a history of CRT, low hemoglobin levels (\< 12.5 g/dl), and malnutrition. A growing concern is the role of nutritional status, with sarcopenia as an emergent risk factor for post-operative complications, because muscle wasting negatively influences wound healing and overall recovery. Salivary stent placement, 3-layers neopharyngeal sutures, cricopharyngeal myotomy and prophylactic use of vascularized flaps are possible protective factors to reduce the risk of PCF. Despite these evidences, it remains unclear which are the best candidates for flap reconstruction, as well as which preoperative risk factors influence the risk of PCF. The rationale of this ambispective monocentric study is to identify the risk factors statistically significant associated with the development of PCF and the influence of preoperative sarcopenia on postoperative complications risks following TL and TPL.

Conditions

• Laryngeal and Hypopharyngeal Tumors

Interventions

Type	Name	Description
PROCEDURE	surgical flap	Pedicled or free flap was harvested and placed over the pharyngeal suture (on-lay) following TL or tunnelled to reconstruct wide defects (in-lay) after TPL.

Timeline

• Start date: 2025-03-14
• Primary completion: 2030-12-01
• Completion: 2030-12-31
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Italy