Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland
Primary Purpose
Methylene Blue, Recurrent Laryngeal Nerve Injuries, Parathyroid Gland
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
methylene blue identification
Sponsored by
About this trial
This is an interventional prevention trial for Methylene Blue
Eligibility Criteria
Inclusion Criteria:
- Age of 16 years and older.
- Both sexes.
- Patients who are candidate for thyroid surgery and euthyroid.
Exclusion Criteria:
- - Patients with hyper- or hypo-thyroid status.
- Patients who were unfit for surgery.
- Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
- Patients with thyroid malignancy by preoperative FNAC.
- Patients with hypersensitivity to methylene blue were excluded.
Sites / Locations
- Zagazig university hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Sham Comparator
Arm Label
anatomical identification
methylene blue identification
Arm Description
thyroidectomy was done with identification of both RLN and parathyroid gland done on anatomical basis
thyroidectomy was done with identification of both RLN and parathyroid gland done using methylene blue spray (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area
Outcomes
Primary Outcome Measures
detection of the recurrent larngeal nerve unstained
the methylene blue dye stain the background and the RLN appears unstained
detection of the parathyroig glands
the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05113628
Brief Title
Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland
Official Title
Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Glands During Thyroidectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery. Yet, it carries a risk for intraoperative complications. The most distressing complications are recurrent laryngeal nerve and parathyroid injuries. Methylene blue spray is a technique than can be used for easy identification of both recurrent laryngeal nerve and parathyroid glands so we can avoid their injuries.
Detailed Description
Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus. Thyroid surgery is one of the most frequently operated Head and Neck surgeries. Post-thyroidectomy complications are not uncommon. Parathyroids and Recurrent Laryngeal Nerve (RLN) are two of the complications of thyroidectomy that cause significant postoperative morbidity Due to the advances in thyroids surgeries, the occurrence of postoperative complications has been decreased, but when occurred, they cause lifelong handicap. The most important complications encountered are injury to the RLN and parathyroids. Meticulous dissection is a key factor in minimizing the occurrence of complications During thyroidectomy, careful dissection can protect the parathyroid glands and RLN. Various methods were used including capsular dissection, attention to protection of the arterial supply to parathyroids, avoiding unnecessary manipulation in the area of RLN Methylene blue spraying is a new technique that allows identification of both parathyroid glands and recurrent laryngeal nerves
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methylene Blue, Recurrent Laryngeal Nerve Injuries, Parathyroid Gland
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anatomical identification
Arm Type
No Intervention
Arm Description
thyroidectomy was done with identification of both RLN and parathyroid gland done on anatomical basis
Arm Title
methylene blue identification
Arm Type
Sham Comparator
Arm Description
thyroidectomy was done with identification of both RLN and parathyroid gland done using methylene blue spray (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area
Intervention Type
Diagnostic Test
Intervention Name(s)
methylene blue identification
Intervention Description
After ligation of the middle thyroid vein and the upper pole of the thyroid, the thyroid lobe was retracted medially and diluted methylene blue (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area. This area contains structures including recurrent laryngeal nerve, parathyroid glands, and inferior thyroid vessels which were observed After spraying.
The vocal cord mobility was assessed intraoperatively by the anesthesiologist at time of extubation. The serum calcium was measured on the 2nd postoperative day. There was no routine use of postoperative calcium supplementation. Hypocalcemia was defined when the serum calcium level was less than 8 mg/dl.
Primary Outcome Measure Information:
Title
detection of the recurrent larngeal nerve unstained
Description
the methylene blue dye stain the background and the RLN appears unstained
Time Frame
one minute after dye application
Title
detection of the parathyroig glands
Description
the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes
Time Frame
3 minutes after dye application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 16 years and older.
Both sexes.
Patients who are candidate for thyroid surgery and euthyroid.
Exclusion Criteria:
- Patients with hyper- or hypo-thyroid status.
Patients who were unfit for surgery.
Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
Patients with thyroid malignancy by preoperative FNAC.
Patients with hypersensitivity to methylene blue were excluded.
Facility Information:
Facility Name
Zagazig university hospitals
City
Zagazig
ZIP/Postal Code
44511
Country
Egypt
12. IPD Sharing Statement
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Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland
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