Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

NCT05367869 | Unknown

• 1 other identifier: Qena Oncology Center
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Impact of Intraoperative Spraying methylene blue In thyroidectomy

Conditions

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Keywords

methylene blue; spraying; intraoperative; thyroidectomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Hoarseness of voice

  3 months

• Stridor

  3 months

• Hypoparathyroidism

  3 months

• Hypocalcaemia

  3 months

Study Arms (1)

Intraoperative Spraying Methylene Blue In Thyroidectomy

EXPERIMENTAL

Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Interventions

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy 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

Intraoperative Spraying Methylene Blue In Thyroidectomy

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qena Oncology Center: lead

MeSH Terms

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Remon Elia Lukas, Specialist Surgical Oncology

  Qena Oncology Center

  STUDY DIRECTOR

• Mohamed Taha Mousa, Resident Surgical Oncology

  Qena Oncology Center

  STUDY DIRECTOR

• Mina Romany Tawfeek, Specialist General Surgery

  Qena Oncology Center

  STUDY DIRECTOR

• Abdullah Atyah Ali, Ass.Lecture General Surgery

  Qena Oncology Center--Luxor University

  STUDY DIRECTOR

• Ali Hassan, Resident General Surgery

  Qena Oncology Center --Qena University

  STUDY CHAIR

• Mohamed Ahmed Orabi, Specialist Surgical Oncology

  Qena Oncology Center

  PRINCIPAL INVESTIGATOR

• Amr M Makky, Specialist Surgical Oncology

  Qena Oncology Center- Medical Military Academy

  STUDY DIRECTOR

• Mostafa Sayedd Abd el Rahaman, Resident Surgical Oncology

  Qena Oncology Center

  STUDY CHAIR

• Mena Zarief Malaty, Resident General Surgery

  Qena Oncology Center--Nag hammady Hospital

  STUDY CHAIR

• Hussein El Lithy, Resident General Surgery

  Qena Oncology Center--Qena General Hospital

  STUDY CHAIR

• Abobakr Mohammed, Resident General Surgery

  Qena Oncology Center--Qena General Hospital

  STUDY CHAIR

• Mohamed Mahmoud El Zeer, Resident General Surgery

  Qena Oncology Center- Sohag University

  STUDY CHAIR

• Mahmoud Rabeea Ahmed, Resident General Surgery

  Qena Oncology Center-Aswan University

  STUDY CHAIR

• Mohamed Abouelmagd Salem, Prof. Surgical Oncology

  Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University

  STUDY CHAIR

• Mohamed Saeed Ayaty, Ass.Prof. Surgical Oncology

  Qena Oncology Center-National Cancer Institute Cairo University

  STUDY CHAIR

• Mohamed H Mahran, Ass.Prof. Surgical Oncology

  Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University

  STUDY CHAIR

• Mohamed Hasan Abdel-Aal, Director of QOC

  Qena Oncology Center

  STUDY CHAIR

Central Study Contacts

Mohamed Ahmed Orabi, Specialist Surgical Oncology

CONTACT

+2 01001868637; Mohamedorabi5885@gmail.com

Amr M Makky, Specialist Surgical Oncology

CONTACT

+2 010222339139; Amr.mostafa.makky@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of Surgical Oncology

Model Details: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 10, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: about 1year