Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.
NCT ID: NCT04268459
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2020-03-10
2022-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Regular exchange
Patients will be appointed each 3 months for regular exchange of voice prosthesis.
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.
Leakage exchange
Patients will have voice prosthesis exchange when leakage occurs.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Anna Rzepakowska
MD, PhD
Principal Investigators
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Anna Rzepakowska, PhD
Role: STUDY_CHAIR
Medical University of Warsaw
Locations
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Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Zurek 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.
Other Identifiers
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1WF_CT_1_2020
Identifier Type: -
Identifier Source: org_study_id
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