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the Use of Harmonic Scalpel Versus Knot Tying for Total Thyroidectomy

The Use of Harmonic Scalpel Versus Knot Tying for Total Thyroidectomy: A Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01189955
Acronym
HS
Enrollment
130
Registered
2010-08-27
Start date
2008-02-29
Completion date
2009-03-31
Last updated
2010-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Swelling

Keywords

thyroidectomy, harmonic, RLN

Brief summary

Consecutive patients treated for thyroid enlargement at our institution were evaluated for inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were after 1 week, 1 month, and 6 months, Study variables included operative time, length of incision, operative bleeding, postoperative drainage, hospital stay and complication. one hundred and thirty patients with thyroid enlargement were randomized and completed the study.

Detailed description

Patients and method: Consecutive patients treated for thyroid enlargement at our institution were evaluated for inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were after 1 week, 1 month, and 6 months, Study variables included operative time, length of incision, operative bleeding, postoperative drainage, hospital stay and complication.Preoperative preparation was performed for patients with thyrotoxicosis by antithyroid drug, and they were all euthyroid at the time of surgery. The routine pre-operative workup included measurement of thyroid-stimulating hormone and thyroid hormones (T3 and T4), as well as plasma levels of total calcium. In addition, a pre-operative laryngoscopy was performed. A prophylactic antibiotic in the form of a third-generation cephalosporin was administered 2 hours before the operation. The operation was performed with the patient in the supine position under general anesthesia with endotracheal intubation. A Kocher incision, was made at the lower neck crease two finger above suprasternal notch. In the HS group, using the new harmonic scalpel device Focus (Ethicon Endo Surgery, Cincinnati, OH, USA) was used for cutting and coagulation . For closure of and division of superior and inferior arteries and veins we set the instrument at a power 2 i.e. more coagulation. And when smaller vessels like capsule veins we set it to the level 5 i.e. more cutting The superior artery and vein was divided close to the gland to avoid damage to superior laryngeal nerve. And control of any bleeding from the bed using the active blade of harmonic. Finally we insert drain. In the conventional group, mono- and bipolar coagulation, as well as ligatures, were allowed. In both groups, the Intra-operative bleeding was estimated by weighing the gauzes before and after use. Furthermore, blood from suction (when used) was also recorded. Operation time was recorded. Patients were discharged 24 hours after the procedure. Oral antibiotic coverage was recommended after discharge. Plasma levels of total calcium were measured on the first post-operative day. The need for oral substitution with calcium and/or vitamin D analogues during hospital stay and at patient discharge was recorded together with complications. Follow-up was performed on postoperative day 7, and then at 1 month, 3 months, and 6 months. . Patients were also seen at our clinic if they developed symptoms between follow-up visits. At follow-up, serum thyroid hormone concentrations and serum levels of total calcium were measured, and complications recorded. Postoperative laryngoscopy was performed within 4 weeks after surgery in all patients to evaluate vocal cord function. All assessments were conducted by investigators who were blinded to the experimental condition. The primary endpoint was operative time and secondary end points were operative bleeding, postoperative drainage, costs and complications.

Interventions

PROCEDUREHS total thyroidectomy

In the HS group, using the new harmonic scalpel device Focus (Ethicon Endo Surgery, Cincinnati, OH, USA) was used for cutting and coagulation . For closure of and division of superior and inferior arteries and veins we set the instrument at a power 2 i.e. more coagulation. And when smaller vessels like capsule veins we set it to the level 5 i.e. more cutting The superior artery and vein was divided close to the gland to avoid damage to superior laryngeal nerve. And control of any bleeding from the bed using the active blade of harmonic. Finally we insert drain.

PROCEDUREconventional total thyroidectomy

A prophylactic antibiotic in the form of a third-generation cephalosporin was administered 2 hours before the operation. The operation was performed with the patient in the supine position under general anesthesia with endotracheal intubation. A Kocher incision, was made at the lower neck crease two finger above suprasternal notch. In the conventional group, mono- and bipolar coagulation, as well as ligatures, were allowed.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Consecutive patients treated for thyroid enlargement

Exclusion criteria

* patients with one lobe pathology who need hemithyroidectomy, malignant thyroid previous neck operation, or a history of neck irradiation.

Design outcomes

Primary

MeasureTime frame
operative time3 hours

Secondary

MeasureTime frame
operative bleeding30 days postoperative
complications30 days
costs30 days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026