Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.

Summary

The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis.

There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.

Conditions

• Vocal Cord Paralysis Unilateral

Interventions

PROCEDURE

Thyroplasty

This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously.

PROCEDURE

Reinnervation

For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63).

Sponsors & Collaborators

• University College Joint Research Office

  collaborator UNKNOWN

• University College London Hospitals

  collaborator OTHER

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Sealed Envelope: Redpill Online Application

  collaborator UNKNOWN

• Royal National Throat, Nose and Ear Hospital

  lead OTHER

Principal Investigators

• Professor Martin Birchall, FRCS,FMedSci · University College London Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• United Kingdom

Study Locations