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

Primary Purpose

Laryngectomy, Voice, Prosthesis Failure

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Provox prosthesis exchange

About this trial

This is an interventional prevention trial for Laryngectomy focused on measuring voice prosthesis, laryngectomy, complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Regular exchange

Leakage exchange

Arm Description

Patients will be appointed each 3 months for regular exchange of voice prosthesis.

Patients will have voice prosthesis exchange when leakage occurs.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fistula colonization with Candida species.

We will compare microbiological results on subsequent prosthesis exchanges in both arms.

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.

Full Information

NCT ID

NCT04268459

First Posted

February 10, 2020

Last Updated

February 10, 2020

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT04268459

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 10, 2020 (Anticipated)

Primary Completion Date

March 10, 2021 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laryngectomy, Voice, Prosthesis Failure

Keywords

voice prosthesis, laryngectomy, complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Regular exchange

Arm Type

Active Comparator

Arm Description

Patients will be appointed each 3 months for regular exchange of voice prosthesis.

Arm Title

Leakage exchange

Arm Type

Active Comparator

Arm Description

Patients will have voice prosthesis exchange when leakage occurs.

Intervention Type

Device

Intervention Name(s)

Provox prosthesis exchange

Intervention Description

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.

Primary Outcome Measure Information:

Title

Comparison of complications rate.

Description

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

Time Frame

Control will be continued for 12 months post laryngectomy.

Secondary Outcome Measure Information:

Title

Fistula colonization with Candida species.

Description

We will compare microbiological results on subsequent prosthesis exchanges in both arms.

Time Frame

Control will be continued for 12 months post laryngectomy.

Title

Prosthesis replacement scheme and patient satisfaction.

Description

Time Frame

Control will be continued for 12 months post laryngectomy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Rzepakowska, PhD

Phone

+48225992521

arzepakowska@wum.edu.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Majszyk, PhD

Phone

+48225992521

daniel.majszyk@wum.edu.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Rzepakowska, PhD

Organizational Affiliation

Medical University of Warsaw

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw

City

Warsaw

ZIP/Postal Code

02-097

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Rzepakowska, PhD

Phone

+48225992521

arzepakowska@wum.edu.pl

First Name & Middle Initial & Last Name & Degree

Ewa Osuch-Wójcikiewicz, Professor

Phone

+48225992521

eosuch@wum.edu.pl

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

Date will become available from April 2022 until April 2023.

IPD Sharing Access Criteria

on request

Learn more about this trial

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

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