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

Prosthesis Failure Clinical Trial

— RvLPE  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04268459
• Other study ID #: 1WF_CT_1_2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2020
• Source: Medical University of Warsaw
• Contact: Anna Rzepakowska, PhD
• Phone: +48225992521
• Email: arzepakowska[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 31, 2022
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy
• Prosthesis Failure
• Voice

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Poland	Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fistula colonization with Candida species.	We will compare microbiological results on subsequent prosthesis exchanges in both arms.	Control will be continued for 12 months post laryngectomy.
Secondary	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.	Control will be continued for 12 months post laryngectomy.