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

NCT07067814 | Completed Phase 2 DMC

• 1 other identifier: FMASU MD17/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Recurrent laryngeal nerve identification

Outcome Measures

Primary Outcomes (1)

• Easy and fast identification of recurrent laryngeal nerve

  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

  Procedure (Time taken for identification of the recurrent laryngeal nerve after delivery of thyroid lobe (in minutes))

Secondary Outcomes (1)

• Lower intra-operative blood loss

  The duration of the procedure ranging from one to two hours

Study Arms (2)

Methylene blue group

ACTIVE COMPARATOR

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.

Drug: Methylene blue group; Procedure: Methylene blue group

Conventional technique group

NO INTERVENTION

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. : - Methylene blue group: After ligation of the superior thyroid 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. 2. : 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

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 16, 2025
• Study Start: June 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-05

Locations

EG (1)