Clinical trial NCT05367869: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Official title: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Keywords: methylene blue
spraying
intraoperative
thyroidectomy
Lead sponsor: Qena Oncology Center
Sponsor class: OTHER_GOV
First posted: 2022-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent laryngeal nerve injury
timeFrame: 2 weeks
measure: Parathyroid gland Injuries
timeFrame: 3 months
measure: Intraoperative injury to trachea
timeFrame: 2 weeks
measure: Operative time
timeFrame: 1 day
measure: Presence of residual or recurrence
timeFrame: 3 months
Secondary outcomes:
measure: Hoarseness of voice
timeFrame: 3 months
measure: Stridor
timeFrame: 3 months
measure: Hypoparathyroidism
timeFrame: 3 months
measure: Hypocalcaemia
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Qena Oncology Center
name: Remon Elia Lukas, Specialist Surgical Oncology
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center
name: Mohamed Taha Mousa, Resident Surgical Oncology
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center
name: Mina Romany Tawfeek, Specialist General Surgery
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center--Luxor University
name: Abdullah Atyah Ali, Ass.Lecture General Surgery
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center --Qena University
name: Ali Hassan, Resident General Surgery
role: STUDY_CHAIR
affiliation: Qena Oncology Center
name: Mohamed Ahmed Orabi, Specialist Surgical Oncology
role: PRINCIPAL_INVESTIGATOR
affiliation: Qena Oncology Center- Medical Military Academy
name: Amr M Makky, Specialist Surgical Oncology
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center
name: Mostafa Sayedd Abd el Rahaman, Resident Surgical Oncology
role: STUDY_CHAIR
affiliation: Qena Oncology Center--Nag hammady Hospital
name: Mena Zarief Malaty, Resident General Surgery
role: STUDY_CHAIR
affiliation: Qena Oncology Center--Qena General Hospital
name: Hussein El Lithy, Resident General Surgery
role: STUDY_CHAIR
affiliation: Qena Oncology Center--Qena General Hospital
name: Abobakr Mohammed, Resident General Surgery
role: STUDY_CHAIR
affiliation: Qena Oncology Center- Sohag University
name: Mohamed Mahmoud El Zeer, Resident General Surgery
role: STUDY_CHAIR
affiliation: Qena Oncology Center-Aswan University
name: Mahmoud Rabeea Ahmed, Resident General Surgery
role: STUDY_CHAIR
affiliation: Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University
name: Mohamed Abouelmagd Salem, Prof. Surgical Oncology
role: STUDY_CHAIR
affiliation: Qena Oncology Center-National Cancer Institute Cairo University
name: Mohamed Saeed Ayaty, Ass.Prof. Surgical Oncology
role: STUDY_CHAIR
affiliation: Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University
name: Mohamed H Mahran, Ass.Prof. Surgical Oncology
role: STUDY_CHAIR
affiliation: Qena Oncology Center
name: Mohamed Hasan Abdel-Aal, Director of QOC
role: STUDY_CHAIR
References: