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

NCT06857396 | Completed

• 1 other identifier: 2025-CHITS-004
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Aerodigestive Tract Neoplasms

Keywords

Tracheostomy; Upper aerodigestive tract neoplasms; Robotic-assisted surgery; Unnecessary surgery; Surgery complications

Outcome Measures

Primary Outcomes (1)

• Tracheostomy completion rate

  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 Outcomes (2)

• Overall survival rate

  Up to 3 hours

• Hospital length of stay

  Up to 3 weeks

Study Arms (1)

PREPA-TRACH Patient cohort

Patients included in the PREPA TRACH surgery protocol

Procedure: PREPA-TRACH

Interventions

PREPA-TRACH PROCEDURE

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

PREPA-TRACH Patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with immediate complete laryngectomy or complete pharyngolaryngectomy
• Patient opposition
• Patient under legal guardianship

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

ENT and oncologic surgery department, Sainte-Musse Hospital

Toulon, Var, 83056, France

Location

Related Publications (2)

• Poissonnet V, Chabrillac E, Schultz P, Moriniere S, Gorphe P, Baujat B, Garrel R, Lasne-Cardon A, Villeneuve A, Chambon G, Fakhry N, Aubry K, Dufour X, Malard O, Mastronicola R, Vairel B, Gallet P, Ceruse P, Jegoux F, Ton Van J, De Bonnecaze G, Vergez S. Airway management during transoral robotic surgery for head and neck cancers: a French GETTEC group survey. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3619-3627. doi: 10.1007/s00405-021-07188-4. Epub 2022 Jan 23.

  PMID: 35066651 BACKGROUND

• Mandal R, Duvvuri U, Ferris RL, Kaffenberger TM, Choby GW, Kim S. Analysis of post-transoral robotic-assisted surgery hemorrhage: Frequency, outcomes, and prevention. Head Neck. 2016 Apr;38 Suppl 1:E776-82. doi: 10.1002/hed.24101. Epub 2015 Jul 15.

  PMID: 25916790 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Guillaume ROUGIER, MD

  CHITS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 7, 2025
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)