Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05285423 |
| Other study ID # |
Prolene VC Lateralization |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Pak Emirates Military Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The larynx performs important functions of the aero-digestive tract, it has a vital role in
the control of breathing, phonation, deglutition, and protection of the lower respiratory
tract from aspiration. Bilateral Vocal cord paralysis is a challenging and at times
debilitating laryngeal dysfunction that has a great social and economic impact on a patient's
life. VC Lateralization, if done accurately and up to the expectations of the patient is very
rewarding. However different surgical procedures which include cordectomy, arytenoidectomy
with or without laser, open surgical methods, and Isshiki type 2 thyroplasty are in practice.
Each has its own profile of benefits and disadvantages. Most of them are technically
difficult and complex, need specialized equipment, and are out of reach of the general ENT
surgeons. The investigator suggests using the Prolene suture stabilized over Prolene mesh for
Vocal Cord Lateralization.
Description:
Introduction: The larynx performs important functions of the aero-digestive tract, it has
vital role in the control of breathing, phonation, deglutition, and protection of the lower
respiratory tract from aspiration. The function of the vocal cord is central to all the
Laryngeal functions, even unilateral paralysis can have a profound effect on overall
laryngeal functionality especially in sound production. Around 80% of all the jobs in the
world are somehow dependent upon social communication. bilateral vocal cord paralysis is a
debilitating laryngeal dysfunction that has a great social and economic impact on a patient's
life. Lateralization thyroplasty (LT), if done accurately and up to the expectations of the
patient is very rewarding. However different surgical procedures which include both
endoscopic cordectomy, arytenoidectomy with or without laser, and open surgical methods
including Isshiki type 2 thyroplasty are in practice. Each method has its own profile of
benefits and disadvantages. Most of them are technically difficult and complex, need
specialized equipment, and are out of reach of the general ENT surgeons and population. In
this regard, the intended aim is to test a prolene suture stabilized over prolene mesh to
lateralize the vocal cord. The Investigator recommends some modifications in the original
technique, which would not require complex measurements and costly equipment. Prolene is
already in use in a wide range of procedures worldwide, approved by the Federal drug
administration in 1997 but it has never been used in the larynx. The objective of this study
is to to explore the efficacy of the prolene suture technique with prolene mesh stabilization
for vocal cord Lateralization in terms of patient satisfaction and voice outcome.
Objective: To evaluate a new approach of vocal cord Lateralization using prolene suture and
mesh.
Study Design: Interventional, prospective study. Place and Duration of study: Ent departments
of multiple tertiary care hospitals of Pakistan from Jan 2022 to May 2022.
Materials and Methods: Hospital ethical committee's approval will be obtained. Patients of
age 15 years onwards, with bilateral vocal cord paralysis/ paresis due to trauma and
idiopathic causes will be included. Patients with neoplasm and underlying muscular dystrophy
are to be excluded from the study. All patients will be counseled properly and given the
choice of intervention by prolene Suture technique. Consenting patients will be subjected to
routine blood investigations, fiber optic laryngoscopy, and imaging with a Computerized
Tomography scan (where applicable). The surgery will be performed under General anesthesia.
Tracheostomy is preferred to get an adequate view of the glottis and to ascertain the extent
of lateralization intraoperatively. The incision will be made at the lower border of thyroid
cartilage under aseptic measures. Skin flaps will be raised in the sub-platysmal plane, strap
muscles will be separated in the midline to expose the laryngeal cartilaginous framework. Two
wide bore Canula (16G) are passed at the levels just above and below the true Vocal cord
under laryngoscopic guidance. Prolene 1-0 suture (thickness 0.3-0.4mm) thread is passed
through the lower cannula and the thread end is brought out through the upper cannula bore
under microscopic forceps guidance. Both the ends are now tied over the thyroid lamina with a
prolene mesh between the knot and the cartilage. the tension of the knot determines the
extent of lateralization needed. Wound will be closed in layers. The patient will be kept in
hospital for a day or more for observation. The success of the surgical procedure will be
measured in terms of post-operative decannulation of tracheostomy and preservation of
reasonable postop voice with comfortable breathing altogether. Tracheostomy decannulation
will be done between 24 to 48 hours post operatively. Preoperatively Voice and breathing
parameters will be noted and Post operatively evaluated at day 14. For subjective evaluation
of ease of breathing, pre and postoperative Visual Analog score (VASb) will be recorded at
Rest and light exercise, graded from 1-10 (1 being the comfortable easy breathing and 10
being the most difficult). Peak expiratory flow (PEF) will be measured for an objective
assessment of ease in breathing both pre and post operatively. For subjective assessment of
voice quality, Visual analog score (VASV) (1-10) will be used both pre and postoperatively.
It will be graded as 1 being the best voice and 10 the worse. For an objective assessment of
the patient's voice, a customized Voice Handicap Index (VHI-10) will be used.
Modified VHI-10 Questionnaire:
My voice makes it difficult for people to hear me. 0 1 2 3 4 5
I run out of air when I talk. 0 1 2 3 4 5
People have difficulty understanding me in a noisy room. 0 1 2 3 4 5
I use a great deal of effort to speak. 0 1 2 3 4 5
My family has difficulty hearing me when I call them throughout the house. 0 1 2 3 4 5
I use my phone less often than I would like to. 0 1 2 3 4 5
I am tense when I am talking to others because of my voice. 0 1 2 3 4 5
I tend to avoid groups of people because of my voice. 0 1 2 3 4 5
People seem irritated with my voice. 0 1 2 3 4 5
People ask what's wrong with my voice. 0 1 2 3 4 5
VHI : Voice Handicap Index 0 = never, 1 = almost never (occasionally), 2 = sometimes, 3 =
almost always, 4 = always
Modified Voice Handicap Index (VHI-10)
Routine monthly follow-up for 3 months will be advised after that.
The results will be analyzed using International IBM SPSS Statistics version 20. Variables
defined would be compared between the preoperative and postoperative groups. For normal data
paired sample t-test would be used and for abnormally distributed data nonparametric t-test
would be used. A P-value of less than 0.05 will be taken as significant.
