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Clinical Trials/NCT04268459
NCT04268459
Unknown
N/A

Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy Considering Complications Rate, Fistula Colonization by Candida Species and Patients Satisfaction Feedback.

Medical University of Warsaw1 site in 1 country70 target enrollmentMarch 10, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Laryngectomy
Sponsor
Medical University of Warsaw
Enrollment
70
Locations
1
Primary Endpoint
Comparison of complications rate.
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
March 31, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Principal Investigator
Principal Investigator

Anna Rzepakowska

MD, PhD

Medical University of Warsaw

Eligibility Criteria

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

Outcomes

Primary Outcomes

Comparison of complications rate.

Time Frame: Control will be continued for 12 months post laryngectomy.

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

Secondary Outcomes

  • Fistula colonization with Candida species.(Control will be continued for 12 months post laryngectomy.)
  • Prosthesis replacement scheme and patient satisfaction.(Control will be continued for 12 months post laryngectomy.)

Study Sites (1)

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