N/A
N=39
A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.
Vocal Cord Paralysis · Phonasthenia · Presbylarynges · Idiopathic Vocal Cord Paralysis · Ca Larynx
Bottom Line
View on ClinicalTrials.gov: NCT04458818 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change in Mean Phonation Time — 7.74; 14.08 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prolene Mesh Vocal Cord Medialization Implant (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Muhammad Rashid
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Phonation Time |
7.74; 14.08 | — |
| PRIMARY Change in Maximum Words Count |
11.33; 18.28 | — |
| PRIMARY Change in Voice Quality on Visual Analogue Score |
4.77; 7.64 | — |
Summary
Larynx performs important functions of the aero-digestive tract, it has vital role in control of breathing, phonation, deglutition and protection of lower respiratory tract from aspiration. Vocal cord paralysis is a common and at times debilitating laryngeal dysfunction that has great social and economic impact on patients life. Medialization thyroplasty (MT), if done accurately and up to the expectations of the patient is very rewarding. However different materials with some modifications in the technique of the classical Isshiki type 1 thyroplasty is in practice, each with its own profile of benefits and disadvantages. Most of them are costly and out of reach of general population. In this regard, we aim to test a prolene mesh implant, which is easily available and can be placed with relative ease.
Eligibility Criteria
Inclusion Criteria
- Age more than 15 years
- Vocal cord paralysis
Exclusion Criteria
- Patients with neoplasms
- Trauma
- Muscular dystrophies
Data sourced from ClinicalTrials.gov (NCT04458818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.