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 (RLN)

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Procedure: Methylene blue group

Study type: Interventional

Funder types: Other

Identifiers

NCT07067814

FMASU MD17/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Methylene blue group

Active Comparator group

Description:

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.

Treatment:

Procedure: Methylene blue group

Procedure: Methylene blue group

Conventional technique group

No Intervention group

Description:

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