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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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.
University Hospital Leuven
Leuven, Belgium
Bundeswehr Krankenhaus
Ulm, Germany
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
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
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
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
Postoperative Results
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Time frame: 1 month
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Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona
Barcelona, Spain