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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 10, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Regular exchange
    • Patients will be appointed each 3 months for regular exchange of voice prosthesis.
  • Active Comparator: Leakage exchange
    • Patients will have voice prosthesis exchange when leakage occurs.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Fistula colonization with Candida species.
    • Time Frame: Control will be continued for 12 months post laryngectomy.
    • We will compare microbiological results on subsequent prosthesis exchanges in both arms.
  • Prosthesis replacement scheme and patient satisfaction.
    • Time Frame: Control will be continued for 12 months post laryngectomy.
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Warsaw
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Rzepakowska, MD, PhD – Medical University of Warsaw
  • Overall Official(s)
    • Anna Rzepakowska, PhD, Study Chair, Medical University of Warsaw
  • Overall Contact(s)
    • Anna Rzepakowska, PhD, +48225992521, arzepakowska@wum.edu.pl

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