Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

NCT ID: NCT05367869

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Impact of Intraoperative Spraying methylene blue In thyroidectomy

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intraoperative Spraying Methylene Blue In Thyroidectomy

Group Type EXPERIMENTAL

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qena Oncology Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ahmed Orabi

specialist of Surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Remon Elia Lukas, Specialist Surgical Oncology

Role: STUDY_DIRECTOR

Qena Oncology Center

Mohamed Taha Mousa, Resident Surgical Oncology

Role: STUDY_DIRECTOR

Qena Oncology Center

Mina Romany Tawfeek, Specialist General Surgery

Role: STUDY_DIRECTOR

Qena Oncology Center

Abdullah Atyah Ali, Ass.Lecture General Surgery

Role: STUDY_DIRECTOR

Qena Oncology Center--Luxor University

Ali Hassan, Resident General Surgery

Role: STUDY_CHAIR

Qena Oncology Center --Qena University

Mohamed Ahmed Orabi, Specialist Surgical Oncology

Role: PRINCIPAL_INVESTIGATOR

Qena Oncology Center

Amr M Makky, Specialist Surgical Oncology

Role: STUDY_DIRECTOR

Qena Oncology Center- Medical Military Academy

Mostafa Sayedd Abd el Rahaman, Resident Surgical Oncology

Role: STUDY_CHAIR

Qena Oncology Center

Mena Zarief Malaty, Resident General Surgery

Role: STUDY_CHAIR

Qena Oncology Center--Nag hammady Hospital

Hussein El Lithy, Resident General Surgery

Role: STUDY_CHAIR

Qena Oncology Center--Qena General Hospital

Abobakr Mohammed, Resident General Surgery

Role: STUDY_CHAIR

Qena Oncology Center--Qena General Hospital

Mohamed Mahmoud El Zeer, Resident General Surgery

Role: STUDY_CHAIR

Qena Oncology Center- Sohag University

Mahmoud Rabeea Ahmed, Resident General Surgery

Role: STUDY_CHAIR

Qena Oncology Center-Aswan University

Mohamed Abouelmagd Salem, Prof. Surgical Oncology

Role: STUDY_CHAIR

Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University

Mohamed Saeed Ayaty, Ass.Prof. Surgical Oncology

Role: STUDY_CHAIR

Qena Oncology Center-National Cancer Institute Cairo University

Mohamed H Mahran, Ass.Prof. Surgical Oncology

Role: STUDY_CHAIR

Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University

Mohamed Hasan Abdel-Aal, Director of QOC

Role: STUDY_CHAIR

Qena Oncology Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Ahmed Orabi, Specialist Surgical Oncology

Role: CONTACT

+2 01001868637

Amr M Makky, Specialist Surgical Oncology

Role: CONTACT

+2 010222339139

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Qena Oncology Center

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.