Could a simple surgical step save patients from unneeded tracheostomy?
NCT ID NCT06857396
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new approach called PREPA-TRACH for patients undergoing robotic surgery for head and neck cancers. Instead of completing a tracheostomy (a hole in the windpipe) right away, surgeons expose the trachea but leave it intact, only making the incision later if needed. The goal is to avoid unnecessary tracheostomies and their complications, like infections and trouble swallowing, while keeping patients safe. The study included 81 adults and measured how many ultimately needed a full tracheostomy and how many survived without airway problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tracheal exposure without tracheostomy completion (PREPA-TRACH protocol)
- What this could lead to
- If successful, this protocol could reduce the need for tracheostomy in many patients, lowering risks like infection and swallowing problems while maintaining safety.
- What could go wrong
- This is a single-center, completed study with 81 patients, so results may not apply to all hospitals or patient groups. The protocol still requires close monitoring and may not prevent all airway emergencies.
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
-
81 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
Jul 2025
- 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
All patients managed for an upper airway and digestive tract carcinoma with a trans-oral robotic surgery with tracheal exposure performed during the surgical procedure without immediate tracheotomy completion.
- 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 Hide 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: * Adult patients (≥ 18 years) * All patients managed for an upper airway and digestive tract carcinoma with trans-oral robotic surgery, with tracheal exposure performed during the surgical procedure without immediate tracheostomy completion. Exclusion Criteria: * Patients with immediate complete laryngectomy or complete pharyngolaryngectomy * Patient opposition * Patient under legal guardianship
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Upper aerodigestive tract neoplasms are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ENT and oncologic surgery department, Sainte-Musse Hospital
Toulon, Var, 83056, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.