15 and older, any sex, with Vocal Cord Paralysis or Phonasthenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Mean Phonation TimePrimary· Preoperative and 14th Postoperative day
Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.
pre operative
Group
Value
95% CI
Prolene Mesh Implant
7.74
± 1.712
post operative
Group
Value
95% CI
Prolene Mesh Implant
14.08
± 3.390
Change in Maximum Words CountPrimary· Preoperative and 14th Postoperative day
Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.
pre operative
Group
Value
95% CI
Prolene Mesh Implant
11.33
± 3.359
post operative
Group
Value
95% CI
Prolene Mesh Implant
18.28
± 5.047
Change in Voice Quality on Visual Analogue ScorePrimary· Preoperative and 14th Postoperative day
For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.
pre operative
Group
Value
95% CI
Prolene Mesh Implant
4.77
± 1.224
post operative
Group
Value
95% CI
Prolene Mesh Implant
7.64
± 1.308
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year follow up was kept for all the patients..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Muhammad Rashid
Last refreshed: 29 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04458818.