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Completed

NCT Number: NCT06857396

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

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.

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Key information

Conditions

Upper Aerodigestive Tract Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT and oncologic surgery department, Sainte-Musse Hospital

Toulon, Var, 83056, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREPA-TRACH

Procedure

Tracheal exposure without tracheostomy completion during trans-oral robotic oncologic surgery

Primary outcomes

  1. Tracheostomy completion rate

    Time frame: Up to 3 hours

    The number of post-operatory complete tracheostomies finally performed over the total number of patients included in the PREPA-TRACH protocol will be calculated.

Secondary outcomes

  1. Overall survival rate

    Time frame: Up to 3 hours

    Number of patients included in the PREPA-TRACH protocol who died because of post-operatory asphyxia.

  2. Hospital length of stay

    Time frame: Up to 3 weeks

    Average hospital length of stay will be calculated depending on whether tracheostomy was finally performed or not.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

Tracheal Exposure Without Tracheostomy Completion : a New Protocol for Airway Management in Trans-oral Robotic Oncologic Surgery

Acronym: TRACH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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