Clinical trial NCT04100954: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngectomy
Keywords: phonatory prosthesis
voice rehabilitation
reinforced voice prosthesis
laryngectomy
total pharyngolaryngectomy
total circular pharyngolaryngectomy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental Cost-Effectiveness Ratio (cost per avoided prosthesis change), based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard prosthesis
timeFrame: 12 months
Secondary outcomes:
measure: Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one
timeFrame: 12 months
measure: Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
measure: Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
timeFrame: Baseline, at 3 months, 6 months, 9 months and 12 months
measure: Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35)
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Quality of voice
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
measure: Quality of voice assessed by the patient
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Patient quality of voice assessed by the patient's relative
timeFrame: Baseline, at 3 months, 6 months, 9 months and 12 months
measure: Trips induced by voice prosthesis replacement
timeFrame: 12 months
measure: Time spent out of home
timeFrame: 12 months
measure: Feeding interruption
timeFrame: 12 months
measure: Interruption of oral communication
timeFrame: 12 months
measure: Frequency of voice prosthesis replacements
timeFrame: 12 months
measure: Lifetime of voice prostheses
timeFrame: 12 months
measure: Complications due to voice prosthesis
timeFrame: 12 months
measure: Patient's pain due to voice prosthesis replacement
timeFrame: at each prosthesis replacement, during the 12 months follow-up
measure: Patient's dysphagia due to voice prosthesis replacement
timeFrame: Baseline and at each prosthesis replacement
measure: Annual net financial benefit of developping the use of reinforced prosthesis
timeFrame: 5 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Caen
country: France
facility: CHU CAEN
city: Montpellier
country: France
facility: Chu Gui de Chauliac
city: Nantes
country: France
facility: Chu Nantes
city: Nîmes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: Clcc Institut Curie
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Tenon
city: Poitiers
country: France
facility: Chru de Poitiers
city: Rennes
country: France
facility: Chru Pontchaillou
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse-Oncopole
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Nantes University Hospital
name: Olivier Malard, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: