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IRCT20260426069165N1 IRCT 2026-05-05 Kerman University of Medical Sciences Comparison of the Effects of Using a Hemostatic Focus Scalpel on Postoperative Complications of Thyroidectomy Compared to the Conventional Method: A Clinical Trial Comparison of the Effects of Using a Hemostatic Focus Scalpel on Postoperative Complications of Thyroidectomy Compared to the Conventional Method: A Clinical Trial 2026-06-22 anticipated 20 Pending https://irct.ir/trial/89808 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients, after signing the written informed consent form, will be allocated to one of the two study groups (HS group or CT group) using a block randomization method (randomized block design). Allocation concealment will be ensured through the use of sealed, opaque, numbered envelopes. The envelope corresponding to each patient will be opened immediately before the start of surgery, after final confirmation of the patient’s eligibility, by a nurse who is not involved in the surgical procedure or outcome assessment. N/A Hemostasis status in open thyroidectomy. Intervention 1: Intervention group: In this group, hemostasis of the thyroid vessels (superior, middle, and inferior thyroid arteries and veins) and division of the thyroid tissue will be performed using the **Focus Harmonic Scalpel** (Ethicon Endo‑Surgery). The use of **sutures** or **electrocautery** will be minimized and applied only when necessary — for example, in cases of bleeding from vessels exceeding the device’s sealing capacity or diffuse oozing. Intervention 2: Control group: In this group, the conventional hemostasis technique will be used. Major vessels will be clamped with surgical clamps and then ligated with absorbable suture material (such as 2‑0 or 3‑0 Vicryl) using the clamp‑and‑tie method. For control of bleeding from smaller vessels and the thyroid bed, monopolar or bipolar electrocautery may also be utilized. 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 A definitive decision regarding the sharing of participants’ de-identified individual data has not yet been made. This is because a thorough assessment of potential data re-identification risks, legal frameworks, and institutional requirements related to data sharing has not been completed. Furthermore, prior to study completion, a comprehensive evaluation of data quality, standardization, and the feasibility of complete anonymization is necessary. A final decision on data sharing will be made after the study concludes and these aspects have been comprehensively evaluated
public Abouzar Pourrashidi
Afzalipour hospital, Imam Khomeini Local Lane
Kerman Iran (Islamic Republic of) 7616913555 +98 913 393 1624 abz_pur@yahoo.com Kerman University of Medical Sciences scientific Abouzar Pourrashidi
Afzalipour hospital, Imam Khomeini Local Lane
Kerman Iran (Islamic Republic of) 7616913555 +98 913 393 1624 abz_pur@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18 years or older Patients scheduled for primary open thyroidectomy (first-time thyroid surgery) Ability to understand the study and to sign a written informed consent form 18 years no limit Both Treatment - Surgery Treatment - Surgery Intervention group: In this group, hemostasis of the thyroid vessels (superior, middle, and inferior thyroid arteries and veins) and division of the thyroid tissue will be performed using the **Focus Harmonic Scalpel** (Ethicon Endo‑Surgery). The use of **sutures** or **electrocautery** will be minimized and applied only when necessary — for example, in cases of bleeding from vessels exceeding the device’s sealing capacity or diffuse oozing. Control group: In this group, the conventional hemostasis technique will be used. Major vessels will be clamped with surgical clamps and then ligated with absorbable suture material (such as 2‑0 or 3‑0 Vicryl) using the clamp‑and‑tie method. For control of bleeding from smaller vessels and the thyroid bed, monopolar or bipolar electrocautery may also be utilized. Duration of surgery. Timepoint: Time from skin incision to skin closure. Method of measurement: Surgical procedure description. Intraoperative blood loss. Timepoint: end of the procedure. Method of measurement: Surgical procedure description. Hypocalcemia. Timepoint: Postoperatively and at 6 months postoperatively. Method of measurement: Lab tests. RLN paralysis. Timepoint: Postoperatively and at 6 months postoperatively. Method of measurement: Patient clinical record. Postoperative hematoma. Timepoint: end of the procedure. Method of measurement: Patient clinical record. Kerman University of Medical Sciences Approved 2026-01-07 The Ethics Committee of Kerman University of Medical Sciences Afzalipour hospital, Imam Khomeini Local Lane Kerman Kerman Iran (Islamic Republic of)