Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy (TL&TPL)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Laryngeal and Hypopharyngeal Tumors
• Intervention / Treatment: Procedure: surgical flap

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with or without reconstructive flap, at Fondazione IRCCS Policlinico San Matteo from January 2015 to December 2030

Description

Inclusion Criteria:

Patients undergoing to TL with direct closure of the pharynx or TPL and reconstruction of the pharynx with a free or pedicled flap in cases of:

• Naive laryngeal neoplasia (cT1-cT4a with possible extension to the esophagus, oropharynx, or hypopharynx);
• Recurrence of laryngeal or hypopharyngeal cancer in patients previously treated with surgical intervention (TLM/CO2 laser or OPHL);
• Recurrence of laryngeal or hypopharyngeal cancer in patients previously treated with RT or CRT;
• Loss of laryngeal function induced by RT, CRT, or OPHL treatment;
• Availability of data according to the assessments that must be made, including a follow-up period of at least 2 months.

Exclusion Criteria:

• Lack of useful data to carry out the assessments related to the study itself

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
reconstructive flap; patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with reconstructive flap, from January 2015 to December 2030	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.
NO reconstructive flap; patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy,without reconstructive flap, from January 2015 to December 2030

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up	Proportion of subjects who develop a post-operative fistula (blind or pharyngo-cutaneous fistula, PCF, with or without the use of a surgical flap, which develop within 30 days from surgery	within 30 days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The association between the use of a surgical flap and the incidence of mid to longterm post-operative fistulas	The rate of development of a mid to longterm post-operative fistula	30 days and at mid to long term.
Potential correlates of fistulas development both within 30 days and at mid to long term	Demographic and medical history; Tumor characteristics; Previous tumor treatment; Laboratory; Perioperative management	30 days and 36 months
The incidence of any post-operative complications	Fistulas and any of the surgical and non surgical complications within 30 days. Surgical complications (require reintervention): Necroses; Hematoma/hemorrage; Neopharyngeal stenosis Non surgical Complications: Hypocalcemia; Anemia requiring blood transfusion; Hypokalemia; Pneumonia; Cardiac complications; Infection	1-36 months follow-up
36 months incidence of tumor related events	Potential correlates will be: The combination of surgical flap and fistula; The lymphnode ratio </≥18 (LNR, calculated as the number of positive lymph nodes divided by the total number of lymph nodes removed, including both positive and negative nodes ); Sarcopenia	36 months after surgery
The prognostic role of both the use of a surgical flap and the development of post-operative fistulas		36 months after surgery

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Marco Benazzo, MD, Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Equipment and Supplies; Surgically-Created Structures; Surgical Flaps
• Other Study ID Numbers: TL&TPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No