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Trial · Interventional

CompletedPhase 2/3Registry data

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

Short name RLN

NCTNCT07067814 (opens ClinicalTrials.gov in a new tab)Other idFMASU MD17/2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
40 participants (actual)
Sponsor
Ain Shams University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
1 Jun 2023
Primary completion
28 Feb 2025
Completion
28 Feb 2025
First posted
16 Jul 2025
Last update posted
16 Jul 2025
Conditions
Time Taken for Identification of Single Recurrent Laryngeal Nerve · Intra-operative Blood Loss

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 2/3

    RLN

    NCT07067814

    1 Jun 2023 to 28 Feb 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of the study is to evaluate the value of injection of methylene blue dye into the inferior thyroid artery for the help of the identification and dissection of recurrent laryngeal nerve, so thyroidectomy could be done with fewer complications in comparison to conventional technique

Interventions

  • Methylene blue groupDrug
  • Methylene blue groupProcedure

Arms2

  • Active comparator

    Methylene blue group

    After ligation of the superior pole, 0.5-1 ml of sterile methylene blue dye was injected into the inferior thyroid artery. The thyroid tissue absorbed the dye, while the RLN remained unstained, appearing as a white structure in the tracheoesophageal groove. This aided in its early and safe identification, reducing the risk of injury during dissection.

  • No intervention

    Conventional technique group

    the RLN was identified based on conventional anatomical landmarks without the use of dye. The nerve was traced along its expected course near the inferior thyroid artery and ligament of Berry

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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))

    Registry description

    Thyroid gland absorbed the dye and got stained blue while the RLN didn't take the dye and appeared as a white structure in the tracheoesophageal groove

Secondary outcomes(1)

  1. Lower intra-operative blood loss

    Time frame · The duration of the procedure ranging from one to two hours

    Registry description

    Intra-operative blood loss was significantly lower in the Methylene blue group in comparison to conventional technique

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * Previous thyroid surgery. * Malignant goiter. * Major cardiac diseases, renal diseases or patients who are unfit for surgery. * Methylene blue allergies. * Pregnancy. * Patients who refuse to participate in the study. * Presence of any preoperative cord pathology or patients with dysphonia.

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