Total Laryngectomy
Conditions
Keywords
laryngectomy, larynx cancer
Brief summary
The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.
Interventions
DEVICEProvox Vega voice prosthesis (20 Fr)
The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system
Sponsors
The Netherlands Cancer Institute
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* total laryngectomy * use Provox2 voice prosthesis * at least two prior prosthesis changes
Exclusion criteria
* current puncture problems (f. ex. infection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Life Time | at replacement of voice prosthesis (maximum 1 year) | Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voice Quality | at 3 months or device change (whichever was first) | Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20. |
| Ease of Insertion | assessed immediately after insertion procedure | The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study. |
| Reason for Replacement | At removal of prosthesis | — |
Countries
Netherlands
Participant flow
Recruitment details
Patients were recruited at the outpatient clinic when they came in for a voice prosthesis replacement.
Participants by arm
| Arm | Count |
|---|---|
| Provox Vega 20 26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Provox Vega 20 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 67.69 years STANDARD_DEVIATION 12.18 |
| Region of Enrollment Netherlands | 26 patients |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Device Life Time
Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.
Time frame: at replacement of voice prosthesis (maximum 1 year)
Population: In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Provox Vega 20 | Device Life Time | 93 days of use | Full Range 81.85 |
Secondary
Ease of Insertion
The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.
Time frame: assessed immediately after insertion procedure
Population: All patients included for insertion evaluation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provox Vega 20 | Ease of Insertion | Very difficult | 1 insertions |
| Provox Vega 20 | Ease of Insertion | Not difficult at all | 20 insertions |
| Provox Vega 20 | Ease of Insertion | A little difficult | 4 insertions |
| Provox Vega 20 | Ease of Insertion | Rather difficult | 1 insertions |
Secondary
Reason for Replacement
Time frame: At removal of prosthesis
Population: 1 patient had his Vega inappropriately removed and received a Provox2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provox Vega 20 | Reason for Replacement | leakage through prosthesis | 16 patients |
| Provox Vega 20 | Reason for Replacement | periprosthetic leakage due to smaller diameter | 5 patients |
| Provox Vega 20 | Reason for Replacement | combination of causes | 4 patients |
Secondary
Voice Quality
Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.
Time frame: at 3 months or device change (whichever was first)
Population: 23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Provox Vega 20 | Voice Quality | 8.4 Units on a scale | Standard Deviation 4.4 |