A Novel Approach for VC Lateralization, With Prolene Suture Stabilized Over Prolene Mesh

NCT05285423 | Completed

• 1 other identifier: Prolene VC Lateralization
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paralysis of Vocal Cords or Larynx; Bilateral Vocal Cord Paralysis

Keywords

Voice Rehabilitation; Vocal cord lateralisation; Prolene mesh implant; Bil abductor Vocal Cord Paralysis

Outcome Measures

Primary Outcomes (5)

• Decannulation with comfortable breathing and reasonable voice

  Successful decannulation of the tracheostomy tube and normal breathing pattern without tracheostomy. (Yes/No)

  14th Postoperative day

• Change in Voice Quality on Visual Analogue Score

  For subjective assessment of voice quality Visual (1-10) analogue score (VASV) will be used both pre and postoperatively. Score 1 being the best voice and 10 the worse.

  Preoperative and 14th Postoperative day

• 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 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 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 Fig 1.1 Modified Voice Handicap Index (VHI-10)

  Preoperative and 14th Postoperative day

• Change in breathing effort on Visual Analogue Score

  For subjective assessment of voice quality Visual analogue score (VASb) will be used both pre and postoperatively. Score 1 being the comfortable easy breathing and 10 being the most difficult.

  Preoperative and 14th Postoperative day

• Peak Expiratory flow during Rest and Light Exercise,

  Objective assessment of Ease of breathing during rest and Light exercise. (Ltrs/sec)

  Preoperative and 14th Postoperative day

Study Arms (1)

Prolene suture technique.

EXPERIMENTAL

The Group of Patients who were offered Vocal Cord Lateralization with prolene suture technique.

Procedure: Novel technique of Vocal cord Laterlization with Prolene suture.

Interventions

Novel technique of Vocal cord Laterlization with Prolene suture. PROCEDURE

The procedure will be performed under General anesthesia, preferably with a tracheostomy so that the extent of vocal cord lateralization could be ascertained intraoperatively.

Prolene suture technique.

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above. Vocal cord paralysis

You may not qualify if:

• Neoplasia Muscular dystrophy trauma Cardiac decompensation Dysfunctional pulmonary variables-

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

ENT Departments

Sialkot, Punjab Province, 51300, Pakistan

Location

MeSH Terms

Conditions

Vocal Cord Paralysis; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad N Karim, FCPS

  CMH Sialkot

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients in othe only arm are provided with vocal cord lateralization with prolene suture technique, and this is known by the patient, health care provider and the assessor.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Muhammad Rashid, Head of The Department Otolaryngology, Kharian, The Principal Investigator.

Model Details: The single group will be offered vocal cord lateralization with prolene suture and mesh implant technique.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: January 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: July 1, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)