the Use of Harmonic Scalpel Versus Knot Tying for Total Thyroidectomy (HS)

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01189955
First received: August 25, 2010
Last updated: August 26, 2010
Last verified: February 2008
  Purpose

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.


Condition Intervention
Thyroid Swelling
Procedure: HS total thyroidectomy
Procedure: conventional total thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Harmonic Scalpel Versus Knot Tying for Total Thyroidectomy: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • operative time [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • operative bleeding [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
  • complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • costs [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HS 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.
Procedure: HS 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.
Other Name: Group 1
Active Comparator: conventional 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.
Procedure: conventional 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.
Other Name: Group 11

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189955

Locations
Egypt
Ayman El Nakeeb
Mansoura, Egypt, Egypt, 335111
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Ayman El Nakeeb, MD Mansoura university, mansoura, Egypt
  More Information

Additional Information:
Publications:
Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT01189955     History of Changes
Other Study ID Numbers: harmonic total thyroidectomy
Study First Received: August 25, 2010
Last Updated: August 26, 2010
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
thyroidectomy
harmonic
RLN

ClinicalTrials.gov processed this record on September 18, 2014