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Completed

NCT Number: NCT01189955

the Use of Harmonic Scalpel Versus Knot Tying for Total Thyroidectomy

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman El Nakeeb

Mansoura, Egypt, 335111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HS total thyroidectomy

Procedure

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.

Other names: Group 1

conventional total thyroidectomy

Procedure

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.

Other names: Group 11

Primary outcomes

  1. operative time

    Time frame: 3 hours

Secondary outcomes

  1. operative bleeding

    Time frame: 30 days postoperative

  2. complications

    Time frame: 30 days

  3. costs

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: HS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2010
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.