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Can a surgical flap prevent a common complication after throat cancer surgery?

NCT ID NCT07287865

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 400 people who had surgery to remove throat cancer (laryngectomy or pharyngolaryngectomy). The goal is to find out which factors, like using a surgical flap or muscle loss (sarcopenia), increase the risk of a fistula—a leak that can cause infection. Researchers hope to better predict and prevent this complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical flap (pedicled or free flap)
What this could lead to
If successful, this could help doctors identify which patients benefit most from flap surgery to prevent fistulas after laryngectomy.
What could go wrong
This is an observational study, not a treatment trial. It won't directly test a new therapy, and results may not change practice immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypopharyngeal carcinoma laryngeal disorder laryngeal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Laryngeal and hypopharyngeal tumors

Contacts and locations

Locations

  • SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia

    Pavia, Pavia, 27100, Italy

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