A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.

NCT04458818 | Completed Results

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

Brief Summary

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.

Conditions

Vocal Cord Paralysis; Phonasthenia; Presbylarynges; Idiopathic Vocal Cord Paralysis; Ca Larynx

Keywords

Voice Rehabilitation; Vocal Medialization; Prolene mesh implant

Outcome Measures

Primary Outcomes (3)

• Change in Mean Phonation Time

  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.

  Preoperative and 14th Postoperative day

• Change in Maximum Words Count

  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.

  Preoperative and 14th Postoperative day

• Change in Voice Quality on Visual Analogue Score

  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.

  Preoperative and 14th Postoperative day

Study Arms (1)

Prolene Mesh Implant

EXPERIMENTAL

The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.

Procedure: Prolene Mesh Vocal Cord Medialization Implant

Interventions

Prolene Mesh Vocal Cord Medialization Implant PROCEDURE

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.

Prolene Mesh Implant

Eligibility Criteria

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

You may qualify if:

• Age more than 15 years
• Vocal cord paralysis

You may not qualify if:

• Patients with neoplasms
• Trauma
• Muscular dystrophies

Sponsors & Collaborators

• Muhammad Rashid: lead

Study Sites (1)

ENT Departments

Kharian, Punjab Province, 500090, Pakistan

Location

MeSH Terms

Conditions

Vocal Cord Paralysis; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Laryngeal Diseases; 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; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms

Results Point of Contact

• Title: Dr Muhammad Noman Karim
• Organization: Combined Military Hospital Kharian, Punjab Pakistan

f9noman@gmail.com

+923313358884

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking. Patients in one arm are provided with prolene mesh implant, and is known by the patient, health care provider and the assessor.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of ENT

Model Details: The single group will be implanted with Prolene mesh made into Swiss rolls and placed in Laryngeal Window between the cartilage and inner periosteum,

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: May 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Locations

PA (1)