Comparison of the Effects of Using a Hemostatic Focus Scalpel on Postoperative Complications of Thyroidectomy Compared to the Conventional Method: A Clinical Trial
This study is designed to compare the efficacy and safety of the Focus Harmonic Scalpel (HS) with the conventional clamp‑and‑tie technique (CT) in adult patients undergoing open thyroidectomy.
Design
This study is a prospective randomized clinical trial (RCT).
Settings and conduct
All surgeries will be performed by one surgeon at Afzalipour Hospital to ensure consistency. Both groups undergo standard open thyroidectomy; the only difference lies in the hemostasis method—Harmonic Scalpel (HS) versus conventional clamp‑and‑tie (CT). Nerve and parathyroid preservation, hemostasis verification, optional drain placement, and standard wound closure are performed in all cases.
Participants/Inclusion and exclusion criteria
The target population includes all adult patients (aged 18 years and older) who are candidates for open thyroidectomy— including hemithyroidectomy, near‑total thyroidectomy, or total thyroidectomy— for the treatment of benign (e.g., multinodular goiter, toxic nodular goiter, Graves’ disease) or malignant thyroid disorders at Afzalipour and Shahid Bahonar Hospitals in Kerman. Patients will be selected using a convenient sampling method.
Intervention groups
Open thyroidectomy will be performed in both groups, with the only difference being the method of hemostasis and division of thyroid vessels and tissue: one group using the conventional clamp‑and‑tie (CT) technique, and the other employing the Harmonic Scalpel (HS) method for hemostasis.
Main outcome variables
Duration of surgery
Intraoperative blood loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260426069165N1
Registration date:2026-05-05, 1405/02/15
Registration timing:prospective
Last update:2026-05-05, 1405/02/15
Update count:0
Registration date
2026-05-05, 1405/02/15
Registrant information
Name
Ehsan Mahmoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 179 8724
Email address
s.em2012@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2027-02-20, 1405/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Using a Hemostatic Focus Scalpel on Postoperative Complications of Thyroidectomy Compared to the Conventional Method: A Clinical Trial
Public title
Comparison of the Effects of Using a Hemostatic Focus Scalpel on Postoperative Complications of Thyroidectomy Compared to the Conventional Method: A Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Kerman University of Medical Sciences
Street address
Afzalipour hospital, Imam Khomeini Local Lane
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2026-01-07, 1404/10/17
Ethics committee reference number
IR.KMU.AH.REC.1404.216
Health conditions studied
1
Description of health condition studied
Hemostasis status in open thyroidectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of surgery
Timepoint
Time from skin incision to skin closure
Method of measurement
Surgical procedure description
2
Description
Intraoperative blood loss
Timepoint
end of the procedure
Method of measurement
Surgical procedure description
Secondary outcomes
1
Description
hypocalcemia
Timepoint
Postoperatively and at 6 months postoperatively
Method of measurement
Lab tests
2
Description
RLN paralysis
Timepoint
Postoperatively and at 6 months postoperatively
Method of measurement
Patient clinical record
3
Description
Postoperative hematoma
Timepoint
end of the procedure
Method of measurement
Patient clinical record
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Abouzar Pourrashidi
Street address
Imam Khomeini Local Lane
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 393 1624
Email
abz_pur@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abouzar Pourrashidi
Street address
Imam Khomeini Local Lane
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 393 1624
Email
abz_pur@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abouzar Pourrashidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Afzalipour hospital, Imam Khomeini Local Lane
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 393 1624
Email
abz_pur@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abouzar Pourrashidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Afzalipour hospital, Imam Khomeini Local Lane
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 393 1624
Email
abz_pur@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abouzar Pourrashidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Afzalipour hospital, Imam Khomeini Local Lane
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 393 1624
Email
abz_pur@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available