Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy (PHRASAL)

Nantes University Hospital (NUH)

Status: Active, not recruiting

Conditions: Laryngectomy

Treatments: Device: Reinforced prosthesis; Device: Standard prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT04100954

RC19_0180

Details and patient eligibility

About

The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients.

This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage.

Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.

Full description

Prosthetic voice rehabilitation is a widespread practice that allows the patient to resume phonation quickly after total laryngectomy/total pharyngolaryngectomy/total circular pharyngolaryngectomy.

When the longevity of the implant is abnormally short (less than 3 months), the multiplication of changes is likely to increase the risk of overall morbidity related to maintaining the functionality of the voice prosthesis and to alter the patient's quality of life.

Reinforced innovative prostheses, currently not supported by the French Social Security, delay the occurrence of intraprosthetic leakage compared to standard prostheses.

This study assesses the economic efficiency from a societal perspective and a one-year time horizon, from vocal rehabilitation with reinforced inter-tracheoesophageal prosthesis versus standard voice prosthesis in case of intra-tracheal leakage in total laryngectomy patients.

Patients are randomized in 2 arms. Arm A usual care with reinforced prosthesis, or arm B usual care with standard prosthesis. Each patient is followed during 12 months.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient treated surgically by total laryngectomy or total pharyngolaryngectomy or total circular pharyngolaryngectomy and carrying a voice prosthesis for at least 12 months
• Patient carrying a standard voice prosthesis and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage
• Patients carrying a voice prosthesis, irrespective of the mark/model, of diameters between 16 and 20 French, and of length between 6 and 14 mm.
• Prosthetic replacement available under local or general anaesthesia
• Patient with primary cancer remission status
• Patient agreeing to participate in the study and having given oral, express and informed consent

Exclusion criteria

• Patient with local, regional or metastatic tumor evolution
• Patient who has had a first voice prosthesis for less than 12 months.
• Patient with peri-prosthetic leakage
• Patient presenting a dysfunction of the voice prosthesis not linked to an intra-prosthetic leak
• Patients whose tracheal fistula is no longer opened, or justifying a new tracheoesophageal puncture
• Patients with a voice prosthesis of a diameter strictly greater than 20 French
• Patients with voice prosthesis of strictly less than 6 mm or greater than 14 mm length
• Patient under anti-fungal treatment during the month prior to inclusion
• Adult protected patients
• Inability to complete the questionnaires
• Patients with an estimated life expectancy of less than 1 year
• Patients not affiliated to French National Health care insurance
• Patients under the protection of Justice
• Pregnant woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Reinforced prosthesis

Experimental group

Description:

Implementation of a reinforced prosthesis with silver coating and double valve, whatever which type of prosthesis the patient previously had.

Treatment:

Device: Reinforced prosthesis

Standard prosthesis

Active Comparator group

Description:

Implementation of a standard prosthesis (simple valve, not reinforced), similar to the prosthesis the patient previously had.

Treatment:

Device: Standard prosthesis