Larynx Cancer
Conditions
Keywords
voice prosthesis, larynx cancer, laryngectomy
Brief summary
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.
Interventions
DEVICEPuncture Set and Flexible Protector
The Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection.
Sponsors
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Provox Vega Puncture Set
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary puncture during total laryngectomy * secondary puncture some time after total laryngectomy
Exclusion criteria
* anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture * not eligible to use a voice prosthesis for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Procedure | immediate observation during surgery | As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of Physician | 1 month | Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used. |
| Cost Effectiveness Calculation | 1 month | cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure |
| Postoperative Results | 1 month | Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire. |
Countries
Belgium, Germany, Netherlands, Spain
Participant flow
Recruitment details
Prospective study, carried out in 5 different medical centers in 4 different countries. Recruitment period runs from November 2009-March 2011
Participants by arm
| Arm | Count |
|---|---|
| Provox Vega Puncture Set Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Provox Vega Puncture Set |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment Belgium | 7 participants |
| Region of Enrollment Germany | 13 participants |
| Region of Enrollment Netherlands | 5 participants |
| Region of Enrollment Spain | 2 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Success Rate of Procedure
As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
Time frame: immediate observation during surgery
Population: Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Provox Vega Puncture Set | Success Rate of Procedure | 23 Nr part. with succesful insertions |
Secondary
Cost Effectiveness Calculation
cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure
Time frame: 1 month
Population: Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Provox Vega Puncture Set | Cost Effectiveness Calculation | 155.4 seconds | Standard Deviation 115.6 |
Secondary
Postoperative Results
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Time frame: 1 month
Population: Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provox Vega Puncture Set | Postoperative Results | Satisfisfied with procedure | 6 Number of patients |
| Provox Vega Puncture Set | Postoperative Results | Would recommend procedure | 6 Number of patients |
Secondary
Satisfaction of Physician
Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.
Time frame: 1 month
Population: Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Provox Vega Puncture Set | Satisfaction of Physician | 26 Number of times new set was preferred |