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

Medical University of Warsaw

Status: Unknown

Conditions: Voice; Laryngectomy; Prosthesis Failure

Treatments: Device: Provox prosthesis exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT04268459

1WF_CT_1_2020

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Regular exchange

Active Comparator group

Description:

Patients will be appointed each 3 months for regular exchange of voice prosthesis.

Treatment:

Device: Provox prosthesis exchange

Leakage exchange

Active Comparator group

Description:

Patients will have voice prosthesis exchange when leakage occurs.

Treatment:

Device: Provox prosthesis exchange