Clinical trial NCT03039465: A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
Official title: A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Cancer
Hypopharynx Cancer
Keywords: Indwelling Trachea-oesophageal Prosthesis
Voice Rehabilitation
Total Laryngectomy
Lead sponsor: HealthCare Global Enterprise Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Voice Quality
timeFrame: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
measure: Change in Presence / Absence of Fluid Leak
timeFrame: Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: HealthCare Global Enterprises Ltd
state: Karnataka
Study officials:
affiliation: Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
name: Vishal US Rao, MS
role: PRINCIPAL_INVESTIGATOR
References: