Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery.

Yet, it carries a risk for intraoperative complications.

The most distressing complications are recurrent laryngeal nerve and parathyroid injuries.

It had two arms (groups): anatomical identification (no intervention) and methylene blue identification (sham comparator).

Thyroidectomy was done with identification of both RLN and parathyroid gland done on anatomical basis.

The registry classes the interventions as diagnostic test.

More on the Plan

Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus.

Thyroid surgery is one of the most frequently operated Head and Neck surgeries.

Post-thyroidectomy complications are not uncommon.

The most important complications encountered are injury to the RLN and parathyroids.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age of 16 years and older. Patients who are candidate for thyroid surgery and euthyroid.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: \- patients with hyper- or hypo-thyroid status; patients who were unfit for surgery; patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-01-15 with completion listed for 2021-06-10.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: detection of the recurrent larngeal nerve unstained (time frame: one minute after dye application). detection of the parathyroig glands (time frame: 3 minutes after dye application).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.