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

NCT04100954 | Unknown

• 1 other identifier: RC19_0180
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 13

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.

Conditions

Laryngectomy

Keywords

phonatory prosthesis; voice rehabilitation; reinforced voice prosthesis; laryngectomy; total pharyngolaryngectomy; total circular pharyngolaryngectomy

Outcome Measures

Primary Outcomes (1)

• 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

  Effectiveness will be measured by the mean of number of prosthesis changes in each arm. Costs will be measured by 1) Outpatient resource consumption collected in a declarative patient questionnaire and 2) Hospital care resources using the database of the Medicalised Information System Program of each recruiting site

  12 months

Secondary Outcomes (17)

• Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one

  12 months

• Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire

  Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement

• Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

  Baseline, at 3 months, 6 months, 9 months and 12 months

• Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35)

  Baseline, 3 months, 6 months, 9 months and 12 months

• Quality of voice

  Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement

Study Arms (2)

Reinforced prosthesis

EXPERIMENTAL

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

Device: Reinforced prosthesis

Standard prosthesis

ACTIVE COMPARATOR

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

Device: Standard prosthesis

Interventions

Reinforced prosthesis DEVICE

Implementation of a reinforced prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.

Reinforced prosthesis

Standard prosthesis DEVICE

Implementation of a standard prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.

Standard prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (13)

Chu Bordeaux

Bordeaux, France

Location

CHU CAEN

Caen, France

Location

Chu Gui de Chauliac

Montpellier, France

Location

Chu Nantes

Nantes, France

Location

Chu Nimes

Nîmes, France

Location

Clcc Institut Curie

Paris, France

Location

Hopital Bichat

Paris, France

Location

Hopital Tenon

Paris, France

Location

Chru de Poitiers

Poitiers, France

Location

Chru Pontchaillou

Rennes, France

Location

Hopital Hautepierre

Strasbourg, France

Location

Institut Universitaire du Cancer de Toulouse-Oncopole

Toulouse, France

Location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Study Officials

• Olivier Malard, Md PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: January 21, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

FR (13)