LaryngectomyRvLPENCT04268459
Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.
A study testing Provox prosthesis exchange in people with Laryngectomy and Voice, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy, Voice, Prosthesis Failure
- What is being tested?
- Provox prosthesis exchange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 10 Mar 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients post laryngectomy with primary insertion of voice prosthesis
Who cannot join
- patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw
Warsaw, 02-097
Anna Rzepakowska, PhD, +48225992521, arzepakowska@wum.edu.pl
Ewa Osuch-Wójcikiewicz, Professor, +48225992521, eosuch@wum.edu.pl
About this study
Official title: 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.
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.
- Conditions
- Laryngectomy, Voice, Prosthesis Failure
- Being tested
- Provox prosthesis exchange
- Keywords
- voice prosthesis, laryngectomy, complications
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox prosthesis exchangeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular exchange | Active comparator | Patients will be appointed each 3 months for regular exchange of voice prosthesis. Receives: Device: Provox prosthesis exchange |
| Leakage exchange | Active comparator | Patients will have voice prosthesis exchange when leakage occurs. Receives: Device: Provox prosthesis exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Control will be continued for 12 months post laryngectomy.
Secondary outcomes (2)
Fistula colonization with Candida species.
We will compare microbiological results on subsequent prosthesis exchanges in both arms.
Measured: Control will be continued for 12 months post laryngectomy.
Prosthesis replacement scheme and patient satisfaction.
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.
Measured: Control will be continued for 12 months post laryngectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start10 Mar 2020 (estimated)
- Primary completion10 Mar 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Rzepakowska, Medical University of Warsaw
- Investigators
- Anna Rzepakowska, PhD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268459
- Sponsor's protocol ID
- 1WF_CT_1_2020
- Acronym
- RvLPE
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39926276Zurek 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.
PubMed 38864228
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04268459
- Acronym / sponsor ID
- RvLPE / 1WF_CT_1_2020
- Conditions
- Laryngectomy, Voice, Prosthesis Failure
- Keywords
- voice prosthesis, laryngectomy, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 10 Mar 2020 (estimated)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Regular exchange | Active comparator | Device: Provox prosthesis exchangePatients will be appointed each 3 months for regular exchange of voice prosthesis. |
| Leakage exchange | Active comparator | Device: Provox prosthesis exchangePatients will have voice prosthesis exchange when leakage occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients post laryngectomy with primary insertion of voice prosthesis
Key exclusion criteria (1 listed)
- patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provox prosthesis exchangeEach 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. | Device | Leakage exchange, Regular exchange |
Primary outcome
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
2 secondary outcomes
Fistula colonization with Candida species.
Time frame: Control will be continued for 12 months post laryngectomy.
Prosthesis replacement scheme and patient satisfaction.
Time frame: Control will be continued for 12 months post laryngectomy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 39926276Zurek 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.
- Derived from this study: PubMed 38864228Zurek 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Rzepakowska, PhD study chair
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provox prosthesis exchange in people with Laryngectomy and Voice, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Rzepakowska, PhD (+48225992521, arzepakowska@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of complications rate. (time frame: Control will be continued for 12 months post laryngectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268459, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.