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

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.

Study Overview

• Status: Unknown
• Conditions: Prosthesis Failure; Voice; Laryngectomy
• Intervention / Treatment: Device: Provox prosthesis exchange

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular exchange; Patients will be appointed each 3 months for regular exchange of voice prosthesis.	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.
Active Comparator: Leakage exchange; Patients will have voice prosthesis exchange when leakage occurs.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Chair: Anna Rzepakowska, PhD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Anticipated): March 10, 2020
• Primary Completion (Anticipated): March 10, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: voice prosthesis, laryngectomy, complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: 1WF_CT_1_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: Date will become available from April 2022 until April 2023.
• IPD Sharing Access Criteria: on request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No