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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

NCT00213863

Vocal Cord Paralysis

UNKNOWN PHASE2

Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.

NCT04268459

Laryngectomy Voice Prosthesis Failure

UNKNOWN NA

Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.

NCT02973152

Vocal Cord Paralysis Unilateral

COMPLETED PHASE2

Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

NCT06579989

Cough Vocal Cord Atrophy Vocal Cord Paresis +3 more

NOT_YET_RECRUITING NA

Establishment of an Artificial Larynx After Total Laryngectomy

NCT01474005

Carcinomatous Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laryngectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reinforced prosthesis

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

Group Type EXPERIMENTAL

Reinforced prosthesis

Intervention Type 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.

Standard prosthesis

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

Group Type ACTIVE_COMPARATOR

Standard prosthesis

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reinforced prosthesis

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

Intervention Type DEVICE

Standard prosthesis

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No