Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Not Applicable

• Conditions: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
• Interventions: Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

• Registration Number: NCT05367869
• Lead Sponsor: Qena Oncology Center

Brief Summary

Impact of Intraoperative Spraying methylene blue In thyroidectomy

Detailed Description

General anaesthesia ,supine position with hyperextension to the neck Low collar incision to the neck , incision to the skin and platysma muscle and fascia ,upper and lower flaps are developed ,separation of strap muscles and identification of the thyroid gland after freeing of investing fascia Ligation of the middle thyroid vein and ligation and separation of the superior pedicle away from the external laryngeal nerve At this point of operation and before ligation of inferior pedicle, methylene blue 0.05% spraying is applied to the field the amount varies according to size of the thyroid lobe and variation in population and neck size Thyroid gland stained by bluish color , recurrent laryngeal nerve not stained or minimally stained so we can avoid injury to it parathyroid glands get red of the stain after about 3 minutes so we can avoid injury to it thyroid gland lose its stain in about 15 minutes so we can remove any residual and decrease residual tissue or recurrence

Study Timeline

• Study First Submitted: 2022-04-28
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-10
• Last Update Submitted: 2022-05-22
• Last Update Posted: 2022-05-24
• Study Start: 2022-06-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

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

Inclusion Criteria

• Both sexes
• Age more than 15 years
• All pathologies need surgery eg. (mutinodular goiter, malignancy , thyroid nodule,.....etc
• Total thyroidectomy

Exclusion Criteria

• Pregnant females
• Previous neck surgery or recurrent thyroid surgery
• Subtotal or partial thyroidectomy
• Age less than 15 years
• Preoperative affection to vocal cord
• Preoperative hypocalcaemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Spraying Methylene Blue In Thyroidectomy	Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy	-

Primary Outcome Measures

Name	Time	Method
Presence of residual or recurrence	3 months
Operative time	1 day
Intraoperative injury to trachea	2 weeks
Parathyroid gland Injuries	3 months
Recurrent laryngeal nerve injury	2 weeks

Secondary Outcome Measures

Name	Time	Method
Stridor	3 months	temporary or permanent (by clinical evaluation and vocal cord examination)
Hypoparathyroidism	3 months	temporary or permanent (level of para thormone hormone )
Hoarseness of voice	3 months	temporary or permanent (by clinical evaluation and vocal cord examination)
Hypocalcaemia	3 months	temporary or permanent ( level of total and free serum calcium )