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Tracheal Exposure Without Tracheostomy Completion in Trans-oral Robotic Oncologic Surgery

NCT06857396 · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Updated 12 Feb 2026

What is being tested
PREPA-TRACH
For
Upper Aerodigestive Tract Neoplasms
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 81 people. The full rules are on the registry page.
Where
France
When
Starts or started 7 March 2025, ends 7 July 2025. Registered 4 March 2025.
Results
None posted yet.

In the researchers' words

Upper aerodigestive tract neoplasms surgery results in important trauma, including swelling (oedemas) that can lead to respiratory tract obstruction and death from suffocation. To prevent this, protective tracheostomy is performed, allowing patients to breathe through a cannula during the critical phase. Although tracheostomy is reassuring, it presents complications, including swallowing disorders, refeeding delay and pulmonary infections. It generates anxiety for patients and can prevent them from communicating, which can affect their psychological well-being during hospitalization. In Sainte Musse Hospital, patients who undergo upper aerodigestive tract neoplasms surgery are continuously monitored in intensive care unit. For some "at risk" patients, tracheostomy preparation is performed during operation with tracheal exposure but no incision. If dyspnea occurs, reanimators can quickly access to trachea and proceed to tracheostomy completion. This method, called PREPA-TRACH, avoids unnecessary tracheostomies while minimizing risks for the patients who would need it. Study purpose is to assess the security and reliability of this PREPA-TRACH protocol.
ClinicalTrials.gov, NCT06857396

Sites

  • ENT and oncologic surgery department, Sainte-Musse HospitalToulon, Var, France