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

Completed

• Conditions: Upper Aerodigestive Tract Neoplasms

• Registration Number: NCT06857396
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Study First Posted: 2025-03-04
• Study Start: 2025-03-07
• Primary Completion: 2025-07-07
• Study Completion: 2025-07-07
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tracheostomy completion rate	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 Outcome Measures

Name	Time	Method
Overall survival rate	Up to 3 hours	Number of patients included in the PREPA-TRACH protocol who died because of post-operatory asphyxia.
Hospital length of stay	Up to 3 weeks	Average hospital length of stay will be calculated depending on whether tracheostomy was finally performed or not.

Trial Locations

Locations (1)

ENT and oncologic surgery department, Sainte-Musse Hospital; 🇫🇷 Toulon, Var, France