Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland

Not Applicable

Completed

• Conditions: Methylene Blue; Parathyroid Gland; Recurrent Laryngeal Nerve Injuries
• Interventions: Diagnostic Test: methylene blue identification

• Registration Number: NCT05113628
• Lead Sponsor: Zagazig University

Brief Summary

Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery. Yet, it carries a risk for intraoperative complications. The most distressing complications are recurrent laryngeal nerve and parathyroid injuries. Methylene blue spray is a technique than can be used for easy identification of both recurrent laryngeal nerve and parathyroid glands so we can avoid their injuries.

Detailed Description

Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus. Thyroid surgery is one of the most frequently operated Head and Neck surgeries. Post-thyroidectomy complications are not uncommon. Parathyroids and Recurrent Laryngeal Nerve (RLN) are two of the complications of thyroidectomy that cause significant postoperative morbidity Due to the advances in thyroids surgeries, the occurrence of postoperative complications has been decreased, but when occurred, they cause lifelong handicap. The most important complications encountered are injury to the RLN and parathyroids. Meticulous dissection is a key factor in minimizing the occurrence of complications During thyroidectomy, careful dissection can protect the parathyroid glands and RLN. Various methods were used including capsular dissection, attention to protection of the arterial supply to parathyroids, avoiding unnecessary manipulation in the area of RLN Methylene blue spraying is a new technique that allows identification of both parathyroid glands and recurrent laryngeal nerves

Study Timeline

• Study Start: 2020-01-15
• Primary Completion: 2021-06-10
• Study Completion: 2021-07-15
• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age of 16 years and older.
• Both sexes.
• Patients who are candidate for thyroid surgery and euthyroid.

Exclusion Criteria

• • Patients with hyper- or hypo-thyroid status.
• Patients who were unfit for surgery.
• Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
• Patients with thyroid malignancy by preoperative FNAC.
• Patients with hypersensitivity to methylene blue were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylene blue identification	methylene blue identification	thyroidectomy was done with identification of both RLN and parathyroid gland done using methylene blue spray (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area

Primary Outcome Measures

Name	Time	Method
detection of the recurrent larngeal nerve unstained	one minute after dye application	the methylene blue dye stain the background and the RLN appears unstained
detection of the parathyroig glands	3 minutes after dye application	the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes

Trial Locations

Locations (1)

Zagazig university hospitals; 🇪🇬 Zagazig, Egypt