Skip to content

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 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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07067814
Acronym
RLN
Enrollment
40
Registered
2025-07-16
Start date
2023-06-01
Completion date
2025-02-28
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Recurrent laryngeal nerve identification

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.

Interventions

DRUGMethylene 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Easy and fast identification of recurrent laryngeal nerveProcedure (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

MeasureTime frameDescription
Lower intra-operative blood lossThe duration of the procedure ranging from one to two hoursIntra-operative blood loss was significantly lower in the Methylene blue group in comparison to conventional technique

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026