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

NCT ID: NCT07067814

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-02-28

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

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Methylene blue group

Intervention Type: 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

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University

Cairo, Abbassia, Egypt

Countries

Egypt

Other Identifiers

FMASU MD17/2023

Identifier Type: -

Identifier Source: org_study_id