A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.
Phase: NA
Conditions: Vocal Cord Paralysis, Phonasthenia, Presbylarynges, Idiopathic Vocal Cord Paralysis, Ca Larynx
Sponsor: Muhammad Rashid

 
 
 
 
A NOVEL TECHNIQUE FOR THYROPLASTY 
TYPE 1, WITH PROLENE MESH IMPLANT. 
NCT04458818 
Date: 3 Mar 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Objective: To evaluate a new approach of vocal cord medialization using prolene mesh 
as an implant material for thyroplasty type 1. 
Study Design: Interventional, prospective study. 
Place and Duration of study: Ent unit of a tertiary care hospital in Pakistan from May 
2020 to January 30 2021. 
Materials and Methods: Patients of age 15 years onwards and with vocal cord paralysis/ 
paresis due to multiple causes were included in the study. Patients with neoplasm, trauma 
and underlying muscular dystrophy were excluded. All patients were counselled properly 
and given the choice of intervention by prolene mesh implant. Consenting patients were 
subjected to routine blood investigations with fiber optic laryngoscopy and imaging with 
Computerized Tomography scan (where applicable). Procedure was be performed under 
local anesthesia with mild sedation, so that the patient will remain vocally responsive for 
the assessment of voice and breathing intraoperatively.  Pre and postoperative voices 
were 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’ and 
Maximum words count (MWC) in a single breath (counting numbers) were recorded pre 
and post operatively. Maximum three attempts were allowed to each patient and the 
better score of the three was recorded in the data. For subjective assessment of voice 
quality Visual (1-10) analogue score (VAS) was used both pre and postoperatively.  
 
Hospital ethical committee’s approval was taken and clinical trial registration was 
obtained from clinicaltrials.org. The surgery will be performed under local anesthesia 
(lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min 
(only sedative dose) will be administered, so that the patient remains vocally responsive 
during the procedure. Incision will be made at the lower border of thyroid cartilage under 
aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be 
separated in the midline to expose the laryngeal cartilaginous framework. A simple 
laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss 
roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis 
will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after 
that. 
 
The results will be analyzed using IBM SPSS Statistics version 20. Variables 
defined would be compared between the pre-operative and postoperative groups. For 
normal data paired sample t-test would be used and for abnormally distributed data non 
parametric t-test would be used. P-value of less than 0.05 will be taken as significant. 
Results: In this study, 39 patients satisfied the inclusion criteria. There were 23 females 
(38.5%) and 15 male (61.50%) patients. 26 patients (66.67%) had unilateral Vocal Cord 

dysfunction while 13 (33.33%) had bilateral dysfunction. 46.15% (n=18) of these were 
post thyroidectomy, 20.51% (n=8) patients had idiopathic vocal cord paralysis and 
33.33% (n=13) had miscellaneous causes. The median time passed since development 
of disease to the time of surgery was 6 months with a range of 2 months to 120 months. 
The categorical data analysis was done with paired sample t-test, which indicated 
an improvement in Visual analogue (1-10) score of voice quality post operatively from 
4.77 to 7.64 (p value <0.001). MWC increased from 11.33 to 18.28 (p value <0.001). The 
median increase in MPT in our study was about 5 seconds (n=39) (p value <0.001). For 
male patients median MPT increase was 7 seconds (n=15) and for females 4.5 seconds 
(n=24). These parameters indicated significant benefit to the patient and improvement in 
the quality of life. 
 
There were no major complications observed in our study except for one instance 
of skin infection and hematoma. There were no graft displacements, extrusions and 
airway obstruction in our study. Four of our patients suffered temporary voice change due 
to upper respiratory tract infection which recovered in a span 5 days.