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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREPA-TRACH Patient cohort | Patients included in the PREPA TRACH surgery protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREPA-TRACH | Procedure | Tracheal exposure without tracheostomy completion during trans-oral robotic oncologic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | Number of patients included in the PREPA-TRACH protocol who died because of post-operatory asphyxia. | Up to 3 hours |
| Hospital length of stay | Average hospital length of stay will be calculated depending on whether tracheostomy was finally performed or not. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume ROUGIER, MD | CHITS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT and oncologic surgery department, Sainte-Musse Hospital | Toulon | Var | 83056 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35066651 | Background | 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. | |
| 25916790 |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 3 weeks |
| 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. |