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

Not Applicable

Completed

• Conditions: Time Taken for Identification of Single Recurrent Laryngeal Nerve; Intra-operative Blood Loss
• Interventions: Procedure: Methylene blue group

• Registration Number: NCT07067814
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-05
• Study First Submitted: 2025-07-06
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylene blue group	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.

Primary Outcome Measures

Name	Time	Method
Easy and fast identification of recurrent laryngeal nerve	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 Outcome Measures

Name	Time	Method
Lower intra-operative blood loss	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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abbassia, Egypt