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Completed

NCT Number: NCT07067814

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

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

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Key information

Conditions

Time Taken for Identification of Single Recurrent Laryngeal Nerve Intra-operative Blood Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, Abbassia, Egypt

About this study

The aim of the study is to evaluate the effectiveness of methylene blue dye injection into the inferior thyroid artery for enhancing the intraoperative visualization of the RLN during thyroidectomy. 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. Patients were randomly assigned into two equal groups:

  • Group A: 20 patients underwent injection of methylene blue dye into the inferior thyroid artery to aid in identifying the recurrent laryngeal nerve (RLN).
  • Group B: 20 patients underwent conventional RLN identification during thyroidectomy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylene blue group

Drug

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.

Methylene blue group

Procedure

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.

Primary outcomes

  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))

    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. Lower intra-operative blood loss

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

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Identification of Recurrent Laryngeal Nerve by Injection of Methylene Blue Dye Into the Inferior Thyroid Artery in Comparison to The Conventional Technique During Thyroidectomy, Comparative Study

Acronym: RLN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.