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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngectomy

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2020-01-21
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2019-09-24
• Last updated: 2023-06-06

Locations

13 sites across 1 country: France