Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy (methylene)

May 22, 2022 updated by: Mohamed Ahmed Orabi, Qena Oncology Center
Impact of Intraoperative Spraying methylene blue In thyroidectomy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intraoperative Spraying Methylene Blue In Thyroidectomy
Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qena Oncology Center

Investigators

  • Study Director: 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 Chair: Ali Hassan, Resident General Surgery, Qena Oncology Center --Qena University
  • Principal Investigator: Mohamed Ahmed Orabi, Specialist Surgical Oncology, Qena Oncology Center
  • Study Director: Amr M Makky, Specialist Surgical Oncology, Qena Oncology Center- Medical Military Academy
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2022

Primary Completion (ANTICIPATED)

May 31, 2023

Study Completion (ANTICIPATED)

May 31, 2023

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (ACTUAL)

May 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qena Oncology Center

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Impact of Intraoperative Spraying methylene blue thyroidectomy

IPD Sharing Time Frame

about 1year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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