Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.
RvLPE
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedFebruary 13, 2020
February 1, 2020
1 year
February 10, 2020
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Arms (2)
Regular exchange
ACTIVE COMPARATORPatients will be appointed each 3 months for regular exchange of voice prosthesis.
Leakage exchange
ACTIVE COMPARATORPatients will have voice prosthesis exchange when leakage occurs.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients post laryngectomy with primary insertion of voice prosthesis
You may not qualify if:
- patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw
Warsaw, 02-097, Poland
Related Publications (2)
Zurek M, Czesak M, Majszyk D, Rzepakowska A. Benefit from regular versus leakage-related exchange of voice prostheses in patients post-laryngectomy considering complication rates and patient satisfaction feedback-a randomized case-controlled trial. Front Oncol. 2025 Jan 24;15:1468955. doi: 10.3389/fonc.2025.1468955. eCollection 2025.
PMID: 39926276DERIVEDZurek M, Czesak M, Czerwinska ME, Berezovska D, Niemczyk K, Rzepakowska A. A double-blind randomized clinical trial of inflammatory cytokine and pepsin levels in the saliva of patients with voice prostheses. Head Neck. 2024 Sep;46(9):2116-2122. doi: 10.1002/hed.27847. Epub 2024 Jun 12.
PMID: 38864228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anna Rzepakowska, PhD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 13, 2020
Study Start
March 10, 2020
Primary Completion
March 10, 2021
Study Completion
March 31, 2022
Last Updated
February 13, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Date will become available from April 2022 until April 2023.
- Access Criteria
- on request