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

February 10, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Tracheal Exposure Without Tracheostomy Completion : a New Protocol for Airway Management 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83056
        • ENT and oncologic surgery department, Sainte-Musse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PREPA-TRACH Patient cohort
Patients included in the PREPA TRACH surgery protocol
Procedure: PREPA-TRACH
Tracheal exposure without tracheostomy completion during trans-oral robotic oncologic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 hours
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.
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Guillaume ROUGIER, MD, CHITS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Actual)

July 7, 2025

Study Completion (Actual)

July 7, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-CHITS-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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