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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04268459
Other study ID # 1WF_CT_1_2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 10, 2020
Est. completion date March 31, 2022

Study information

Verified date February 2020
Source Medical University of Warsaw
Contact Anna Rzepakowska, PhD
Phone +48225992521
Email arzepakowska@wum.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick and easy process of voice rehabilitation are main encouraging factors. However, the usage of the prosthesis relates to a significant number of complications rated from 10 to 60%. The most common reported complication is transprosthetic leakage that determines the need of device exchange. However in some patients occur more serious complications eg. periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis, that may require anti-inflammatory treatment, temporary nasogastric tube feeding or surgical procedure. The standard protocol is voice prosthesis exchange due to transprosthetic leakage. Optionally the device could be replaced regularly to prevent both transprosthetic leakage and other complication occurrence.

In the study we plan to compare the benefits from regular (each three month) versus leakage-related exchange of voice prosthesis post laryngectomy including the rate of complications, fistula colonization by Candida species and patients feedback.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date March 31, 2022
Est. primary completion date March 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients post laryngectomy with primary insertion of voice prosthesis

Exclusion Criteria:

- patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Provox prosthesis exchange
Each patient post laryngectomy will be randomly assigned to one arm of intervention. The voice prosthesis exchange in all patients will be performed in local anaesthesia. The microbiological samples with cotton swabs will be collected from tracheoesophageal fistula on prosthesis exchange. The clinical evaluation and patients satisfaction from prosthesis usage will be performed on each exchange.

Locations

Country Name City State
Poland Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of complications rate. In both arms of the study we will compare the incidence of following complications: periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis Control will be continued for 12 months post laryngectomy.
Secondary Fistula colonization with Candida species. We will compare microbiological results on subsequent prosthesis exchanges in both arms. Control will be continued for 12 months post laryngectomy.
Secondary Prosthesis replacement scheme and patient satisfaction. On each voice prosthesis exchange patients will be asked three questions, assessed with Visual Analog Scale, on their feedback on voice prosthesis use, procedure of prosthesis replacement and voice quality. Control will be continued for 12 months post laryngectomy.
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