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IRCT20250331065186N1 IRCT 2025-06-28 Alborz University of Medical Sciences Methylene blue as identifier of Parathyroid Glands Investigating the effect of identifying parathyroid glands using methylene blue on reducing hypocalcemia after thyroidectomy 2025-04-30 anticipated 54 Complete https://irct.ir/trial/82942 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Thyroid disease. Intervention 1: Intervention Group:In this group, patients will undergo a total thyroidectomy procedure following standard surgical protocols, with the addition of methylene blue as an adjunct to facilitate the identification and preservation of the parathyroid glands.The agent used is methylene blue 1%, with a concentration of 10 mg/mL. A total volume of 1 mL (equivalent to 10 mg) will be sprayed once during the surgery using a sterile syringe equipped with a spray nozzle or atomizer. The spray will be applied evenly over the surface of the thyroid lobe and the surrounding area, which includes the likely locations of the parathyroid glands, the recurrent laryngeal nerve, and branches of the inferior thyroid artery.Methylene blue enhances visual differentiation, as the parathyroid glands absorb less dye compared to surrounding tissues, thus helping the surgeon identify and preserve them more effectively. The application of the dye is done only once during the procedure, after full exposure of the thyroid lobe.All other aspects of the surgery are similar to the control group and include the classic open cervical approach, the use of scalpel, electrocautery, suction, and performance of the procedure under general anesthesia. No educational sessions or training interventions will be provided to the surgeons or operating room staff during the study. Intervention 2: Control group: In this group, patients will undergo a total thyroidectomy procedure performed according to the standard protocols, without the use of any adjunctive agents for the identification of the parathyroid glands. Preservation of the parathyroid glands will rely solely on the direct visualization and the experience and skill of the surgeon in distinguishing parathyroid tissue. The surgery will be performed using the classic open cervical approach under general anesthesia. Standard surgical instruments such as scalpel, electrocautery device (Valleylab Force FX, manufactured by Medtronic), and suction will be used throughout the procedure. The general steps of the operation are as follows: a transverse incision will be made along the midline of the neck (Kocher incision); the pretracheal muscles will be retracted; the recurrent laryngeal nerve will be identified and carefully preserved; the thyroid tissue will be identified and completely removed; and maximum effort will be made to preserve the parathyroid glands through direct observation without the use of any dyes or chemical agents. No substances will be used for staining or marking the parathyroid glands. Furthermore, no educational intervention or additional training will be provided to the surgeons or the operating room staff during the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not interested
public Abbas Alizade
Madani hospital, Madani square, Jahanshahr, karaj
Karaj Iran (Islamic Republic of) ۳۱۸۵۸۱۹۳۲۸ +98 26 3350 7042 Abbas.alz7676@gmail.com Karaj University of Medical Sciences scientific Abbas Alizade
Madani Hospital, Madani Square, Jahanshahr Karaj
Karaj Iran (Islamic Republic of) ۳۱۸۵۸۱۹۳۲۸ +98 26 3350 7042 Abbas.alz7676@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) 1. Thyroidectomy surgery for any reason 2. Over 18 years of age 18 years 70 years Both 1. History of calcium disorders 2. Abnormal calcium before surgery 3. Metastatic cancers 4. Previous history of thyroid surgery E07.9 Disorder of thyroid, unspecified Treatment - Surgery Placebo Intervention Group:In this group, patients will undergo a total thyroidectomy procedure following standard surgical protocols, with the addition of methylene blue as an adjunct to facilitate the identification and preservation of the parathyroid glands.The agent used is methylene blue 1%, with a concentration of 10 mg/mL. A total volume of 1 mL (equivalent to 10 mg) will be sprayed once during the surgery using a sterile syringe equipped with a spray nozzle or atomizer. The spray will be applied evenly over the surface of the thyroid lobe and the surrounding area, which includes the likely locations of the parathyroid glands, the recurrent laryngeal nerve, and branches of the inferior thyroid artery.Methylene blue enhances visual differentiation, as the parathyroid glands absorb less dye compared to surrounding tissues, thus helping the surgeon identify and preserve them more effectively. The application of the dye is done only once during the procedure, after full exposure of the thyroid lobe.All other aspects of the surgery are similar to the control group and include the classic open cervical approach, the use of scalpel, electrocautery, suction, and performance of the procedure under general anesthesia. No educational sessions or training interventions will be provided to the surgeons or operating room staff during the study. Control group: In this group, patients will undergo a total thyroidectomy procedure performed according to the standard protocols, without the use of any adjunctive agents for the identification of the parathyroid glands. Preservation of the parathyroid glands will rely solely on the direct visualization and the experience and skill of the surgeon in distinguishing parathyroid tissue. The surgery will be performed using the classic open cervical approach under general anesthesia. Standard surgical instruments such as scalpel, electrocautery device (Valleylab Force FX, manufactured by Medtronic), and suction will be used throughout the procedure. The general steps of the operation are as follows: a transverse incision will be made along the midline of the neck (Kocher incision); the pretracheal muscles will be retracted; the recurrent laryngeal nerve will be identified and carefully preserved; the thyroid tissue will be identified and completely removed; and maximum effort will be made to preserve the parathyroid glands through direct observation without the use of any dyes or chemical agents. No substances will be used for staining or marking the parathyroid glands. Furthermore, no educational intervention or additional training will be provided to the surgeons or the operating room staff during the study. Calcium level. Timepoint: One day before and one day after the operation. Method of measurement: automated techniques using COBAS integra reagents (Cobas Integra, Roche Diagnostics, Switzerland). Alborz University of Medical Sciences Approved 2025-02-22 Ethics committee of Alborz University of Medical Sciences No. 8, Saffarzadeh Alley, Golshahr Street karaj Alborz Iran (Islamic Republic of)