Hypopharynx Cancer, Laryngeal Cancer
Conditions
Keywords
Indwelling Trachea-oesophageal Prosthesis, Voice Rehabilitation, Total Laryngectomy
Brief summary
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient. Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy \> 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for a fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.
Detailed description
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel trachea-oesophageal prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient. Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy \> 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.
Interventions
DEVICEModified Trans-Esophageal Prosthesis
This device is a biomedical grade silicon voice prosthesis with an inner esophageal flange, a stem and an outer tracheal flange. Insertion would be done through a modified 'romovac' inserter set / curved metal inserter (provided with the TEP) and an oesophagoscope in case of secondary insertion would be used. in patients with existing TEP puncture / who require a TEP change, on out-patient basis, the insertion would be done with a novel two-part inserter device (front loading)
Sponsors
HealthCare Global Enterprise Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A single group of patients undergoing the insertion of the prosthesis would be evaluated for voice quality and fluid leak as a measure of success of the intervention.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are surgically and medically fit for undergoing a total laryngectomy +/- partial pharyngectomy. * Patients who have already undergone total laryngectomy +/- partial pharyngectomy and are willing for a secondary voice rehabilitation procedure. * Patient signing the informed consent for procedure after understanding the details
Exclusion criteria
* Partial laryngectomy * Near total laryngectomy * Patient unfit for the procedure * Patients not consenting for the procedure * Patients utilizing alternative ways of post laryngectomy voice rehabilitation (for secondary insertion) * Patients with stricture in pharynx (for secondary insertion) * Partial pharyngectomy reconstruction, not permitting insertion of TEP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Voice Quality | Assessments would be done 6 weeks, 12 weeks and 6 months post surgery | Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP |
| Change in Presence / Absence of Fluid Leak | Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure | Clinical assessment of modified TEP leak after a test fluid feed |
Countries
India
Contacts
Primary ContactVishal US Rao, MS
Backup ContactSatakshi Chatterjee, MS
Outcome results
None listed