Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

Not Applicable

Not yet recruiting

• Conditions: Ligature; Hemorrhage; Recurrent Laryngeal Nerve Injuries; Hypocalcemia
• Interventions: Device: liagsure device

• Registration Number: NCT05684536
• Lead Sponsor: Imam Mohammad ibn Saud Islamic University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-13
• Last Update Posted: 2023-01-13
• Study Start: 2023-01-15
• Primary Completion: 2023-03-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study

Any age

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Exclusion Criteria

• patient undergoing re-do surgery " completion thyroidectomy "

patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ligasure throidectomy	liagsure device	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

Primary Outcome Measures

Name	Time	Method
Post-operative complications	Postoperatively from day of surgery until one week post operatively	Including RLN palsy , hypocalcemia , hemorrhage wound infection