Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

Study Overview
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Brief Summary
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To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .

Detailed Description
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Due to the high vascularity of the thyroid gland and the relatively tiny operative field, rigorous hemostasis is an essential requirement for successful thyroid surgery. Blood vessel ligation and/or ligation are the primary means of attaining hemostasis in thyroidectomy. New technologies have been developed, including a vessel sealing device (ligasure) that seals vessels by fusing the inner layers of the vessel wall with minimal amounts of thermal dispersion burning and tissue friction, thereby minimizing the occurrence of unintentional burns. yet. It is unclear whether the heat conveyed by a ligature can harm the recurrent laryngeal nerve due to its proximity to the berry ligament. thromosis of the inferior parathyroidal gland's supplying artery during dissection may result from alternative prospective delineation of the inferior thyroidal artery using ligasure for dissection. The purpose of this study is to assess the safety and efficacy of ligasure with standard vascular ligation in open thyroid surgery.

Official Title
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Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

Conditions
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Ligature; Hemorrhage, Recurrent Laryngeal Nerve Injuries, Hypocalcemia

Intervention / Treatment
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* Device: liagsure device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study Any age - Exclusion Criteria: patient undergoing re-do surgery  completion thyroidectomy  patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ligasure throidectomy<br>the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery | Device: liagsure device<br>* the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery<br>|
| No Intervention: conventional thyroidectomy<br>with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Including RLN palsy , hypocalcemia , hemorrhage wound infection | Postoperatively from day of surgery until one week post operatively |