Impact of Intraoperative Spraying Methylene Blue In ThyroidectomymethyleneNCT05367869
Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
A study testing Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy in people with Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy, run by Qena Oncology Center.
Trial summary
Impact of Intraoperative Spraying methylene blue In thyroidectomy Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
- What is being tested?
- Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Both sexes
- Age more than 15 years
- All pathologies need surgery eg. (mutinodular goiter, malignancy , thyroid nodule,…..etc
- Total thyroidectomy
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Impact of Intraoperative Spraying methylene blue In thyroidectomy
Read the 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
- Being tested
- Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
- Keywords
- methylene blue, spraying, intraoperative, thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Intraoperative Spraying Methylene Blue In ThyroidectomyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Intraoperative Spraying Methylene Blue In Thyroidectomy | Experimental | Not described Receives: Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent laryngeal nerve injury
Measured: 2 weeks
Parathyroid gland Injuries
Measured: 3 months
Intraoperative injury to trachea
Measured: 2 weeks
Operative time
Measured: 1 day
Presence of residual or recurrence
Measured: 3 months
Secondary outcomes (4)
Hoarseness of voice
temporary or permanent (by clinical evaluation and vocal cord examination)
Measured: 3 months
Stridor
temporary or permanent (by clinical evaluation and vocal cord examination)
Measured: 3 months
Hypoparathyroidism
temporary or permanent (level of para thormone hormone )
Measured: 3 months
Hypocalcaemia
temporary or permanent ( level of total and free serum calcium )
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Intraoperative Spraying Methylene Blue In ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qena Oncology Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Ahmed Orabi, Qena Oncology Center
- Investigators
- Remon Elia Lukas, Specialist Surgical Oncology, Study director, Qena Oncology CenterMohamed Taha Mousa, Resident Surgical Oncology, Study director, Qena Oncology CenterMina Romany Tawfeek, Specialist General Surgery, Study director, Qena Oncology CenterAbdullah Atyah Ali, Ass.Lecture General Surgery, Study director, Qena Oncology Center--Luxor UniversityAli Hassan, Resident General Surgery, Study chair, Qena Oncology Center --Qena UniversityMohamed Ahmed Orabi, Specialist Surgical Oncology, Principal investigator, Qena Oncology CenterAmr M Makky, Specialist Surgical Oncology, Study director, Qena Oncology Center- Medical Military AcademyMostafa Sayedd Abd el Rahaman, Resident Surgical Oncology, Study chair, Qena Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367869
- Sponsor's protocol ID
- Qena Oncology Center
- Acronym
- methylene
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Impact of Intraoperative Spraying methylene blue thyroidectomy
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
- ClinicalTrials.gov ID
- NCT05367869
- Acronym / sponsor ID
- methylene / Qena Oncology Center
- Keywords
- methylene blue, spraying, intraoperative, thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qena Oncology CenterOther government
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Spraying Methylene Blue In Thyroidectomy | Experimental | Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Both sexes
- Age more than 15 years
- All pathologies need surgery eg. (mutinodular goiter, malignancy , thyroid nodule,…..etc
- Total thyroidectomy
Key exclusion criteria (6 listed)
- Pregnant females
- Previous neck surgery or recurrent thyroid surgery
- Subtotal or partial thyroidectomy
- Age less than 15 years
- Preoperative affection to vocal cord
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of Intraoperative Spraying Methylene Blue In ThyroidectomyGeneral 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 | Procedure or surgery | Intraoperative Spraying Methylene Blue In Thyroidectomy |
Primary outcome
Recurrent laryngeal nerve injury
Time frame: 2 weeks
Parathyroid gland Injuries
Time frame: 3 months
Intraoperative injury to trachea
Time frame: 2 weeks
Operative time
Time frame: 1 day
Presence of residual or recurrence
Time frame: 3 months
4 secondary outcomes
Hoarseness of voice
Time frame: 3 months
Stridor
Time frame: 3 months
Hypoparathyroidism
Time frame: 3 months
Hypocalcaemia
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Yes. Impact of Intraoperative Spraying methylene blue thyroidectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remon Elia Lukas, Specialist Surgical Oncology study director
Qena Oncology Center
Mohamed Taha Mousa, Resident Surgical Oncology study director
Qena Oncology Center
Mina Romany Tawfeek, Specialist General Surgery study director
Qena Oncology Center
Questions about this trial
What is this clinical trial studying?
A study testing Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy in people with Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy, run by Qena Oncology Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ahmed Orabi, Specialist Surgical Oncology (+2 01001868637, Mohamedorabi5885@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent laryngeal nerve injury (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.