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

I

Intermunicipal Hospital Center Toulon

Status

Completed

Conditions

Upper Aerodigestive Tract Neoplasms

Treatments

Procedure: PREPA-TRACH

Study type

Observational

Funder types

Other

Identifiers

NCT06857396
2025-CHITS-004

Details and patient eligibility

About

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.

Full description

This retrospective descriptive monocentric study aims at producing a descriptive series of patients who underwent tracheal exposure in case of tracheostomy hoping to avoid them a complete tracheostomy. Its purpose is to demonstrate on one hand the reliability and security of this technique and on the other hand to define some imperative criteria of surgical indication for tracheostomy or no tracheostomy. The number of patients included corresponds to the eligible patients cohort of Hôpital Sainte Musse ENT surgery department over the 10 last years.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

81 participants in 1 patient group

PREPA-TRACH Patient cohort
Description:
Patients included in the PREPA TRACH surgery protocol
Treatment:
Procedure: PREPA-TRACH

Trial contacts and locations

1

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Central trial contact

Asmaa JOBIC

Data sourced from clinicaltrials.gov

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