Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.

Not Applicable

• Conditions: Laryngectomy; Voice; Prosthesis Failure
• Interventions: Device: Provox prosthesis exchange

• Registration Number: NCT04268459
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13
• Study Start: 2020-03-10
• Primary Completion: 2021-03-10
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leakage exchange	Provox prosthesis exchange	Patients will have voice prosthesis exchange when leakage occurs.
Regular exchange	Provox prosthesis exchange	Patients will be appointed each 3 months for regular exchange of voice prosthesis.

Primary Outcome Measures

Name	Time	Method
Comparison of complications rate.	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 Outcome Measures

Name	Time	Method
Fistula colonization with Candida species.	Control will be continued for 12 months post laryngectomy.	We will compare microbiological results on subsequent prosthesis exchanges in both arms.
Prosthesis replacement scheme and patient satisfaction.	Control will be continued for 12 months post laryngectomy.	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.

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw; 🇵🇱 Warsaw, Poland