Comparison Between Two Techniques During Thyroidectomy (Conventional Dissection Technique and Injection of Methylene Blue Dye Into Inferior Thyroid Artery Technique) Regarding Recurrent Laryngeal Nerve Identification and Preservation

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene blue group (active comparator) and Conventional technique group (no intervention).

The registry classes the interventions as drug and procedure.

More on the Plan

Also, this method was compared to conventional RLN identification techniques in terms of nerve identification time, blood loss, complication rates, and postoperative outcomes, while assessing the safety and feasibility of using methylene blue in thyroid surgery.

The study included 40 patients with indications for thyroidectomy due to benign thyroid conditions.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: All patients who present with simple nodular goiter, solitary thyroid nodule, controlled toxic goiter and failed medical treatment with indication for thyroidectomy. Patents undergoing primary surgery (not recurrent). Patients who are willing to undergo surgery under general anesthesia without any preoperative complications or major diseases. Either gender in the age group of 18-60 years.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: previous thyroid surgery; malignant goiter; major cardiac diseases, renal diseases or patients who are unfit for surgery.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2023-06-01 with completion listed for 2025-02-28.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Easy and fast identification of recurrent laryngeal nerve (time frame: Procedure (Time taken for identification of the recurrent laryngeal nerve after delivery of thyroid lobe (in minutes))).

It also tracked 1 secondary outcome, for example Lower intra-operative blood loss.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 40 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.