Total Laryngectomy
Conditions
Keywords
laryngectomy, Provox Vega, voice prosthesis
Brief summary
The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.
Detailed description
Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French. Outcomes were recorded by means of patient questionnaires and device life. It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.
Interventions
DEVICEProvox Vega voice prosthesis 22.5 Fr
The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.
Sponsors
The Netherlands Cancer Institute
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* total laryngectomy * Provox2 user * at least two previous replacements
Exclusion criteria
* patients' refusal * fistula problems * Provox ActiValve users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference | 3 months post insertion, or at end of device life (whichever comes sooner) | Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Life Time | 6 months | Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced. |
Countries
Netherlands
Participant flow
Recruitment details
Patients were recruited by the Netherlands Cancer Institute
Participants by arm
| Arm | Count |
|---|---|
| Provox Vega 22.5 The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Provox Vega 22.5 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age Continuous | 66.42 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment Netherlands | 33 patients |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Patient Preference
Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference.
Time frame: 3 months post insertion, or at end of device life (whichever comes sooner)
Population: All patients that participated in the study and finished it were analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provox Vega 22.5 | Patient Preference | Provox Vega 22.5 | 14 Patients |
| Provox Vega 22.5 | Patient Preference | Provox2 | 7 Patients |
| Provox Vega 22.5 | Patient Preference | No preference | 11 Patients |
Secondary
Device Life Time
Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.
Time frame: 6 months
Population: Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Provox Vega 22.5 | Device Life Time | 74 Days | Full Range 60.8 |