A Novel Approach for VC Lateralization, With Prolene Suture Stabilized Over Prolene Mesh
Condition: Paralysis of Vocal Cords or Larynx; Bilateral Vocal Cord Paralysis
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Novel technique of Vocal cord Laterlization with Prolene suture.
Intervention type(s): Procedure
Intervention description(s): The procedure will be performed under General anesthesia, preferably with a tracheostomy so that the extent of vocal cord lateralization could be ascertained intraoperatively.
Intervention model: Single Group Assignment
Intervention model description: The single group will be offered vocal cord lateralization with prolene suture and mesh implant technique.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Voice Rehabilitation; Vocal cord lateralisation; Prolene mesh implant; Bil abductor Vocal Cord Paralysis