Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Study Overview
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Brief Summary
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Impact of Intraoperative Spraying methylene blue In thyroidectomy

Detailed Description
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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

Official Title
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Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Conditions
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Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Intervention / Treatment
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* Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative Spraying Methylene Blue In Thyroidectomy<br> | Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent laryngeal nerve injury |  | 2 weeks | 
| Parathyroid gland Injuries |  | 3 months | 
| Intraoperative injury to trachea |  | 2 weeks | 
| Operative time |  | 1 day | 
| Presence of residual or recurrence |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoarseness of voice | temporary or permanent (by clinical evaluation and vocal cord examination) | 3 months | 
| Stridor | temporary or permanent (by clinical evaluation and vocal cord examination) | 3 months | 
| Hypoparathyroidism | temporary or permanent (level of para thormone hormone ) | 3 months | 
| Hypocalcaemia | temporary or permanent ( level of total and free serum calcium ) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methylene blue, spraying, intraoperative, thyroidectomy