Tracheal exposure without full tracheostomy in robotic surgery for throat cancer
Tracheal Exposure Without Tracheostomy Completion : a New Protocol for Airway Management in Trans-oral Robotic Oncologic Surgery
This study is testing a new way to prepare for a tracheostomy during throat cancer surgery to see if it can lower complications while still keeping patients safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other |
| Locations | 1 site (Toulon, Var) |
| Trial ID | NCT06857396 on ClinicalTrials.gov |
What this trial studies
This observational study examines a technique called PREPA-TRACH, which involves preparing for a tracheostomy during trans-oral robotic surgery for upper aerodigestive tract neoplasms without completing the procedure unless necessary. The aim is to reduce the complications associated with traditional tracheostomy, such as swallowing disorders and pulmonary infections, while still providing a safety net for patients at risk of respiratory distress. The study will analyze data from patients treated at Sainte Musse Hospital over the past decade to assess the reliability and safety of this approach and to establish criteria for when tracheostomy is needed.
Who should consider this trial
Good fit: Ideal candidates are adult patients (18 years and older) undergoing trans-oral robotic surgery for upper airway and digestive tract carcinoma.
Not a fit: Patients who require immediate complete laryngectomy or pharyngolaryngectomy, or those who oppose the procedure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the complications and psychological distress associated with unnecessary tracheostomy in patients undergoing throat cancer surgery.
How similar studies have performed: While this approach is novel, similar studies have indicated the potential for reducing complications associated with traditional tracheostomy methods.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toulon, Var
- ENT and oncologic surgery department, Sainte-Musse Hospital — Toulon, Var, France (Recruiting)
Study contacts
- Study coordinator: Asmaa JOBIC
- Email: asmaa.jobic@ch-toulon.fr
- Phone: 0483772061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.