Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

NCT ID: NCT05684536

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-04-01

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.

Conditions

Ligature; Hemorrhage; Recurrent Laryngeal Nerve Injuries; Hypocalcemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ligasure throidectomy

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

Group Type: ACTIVE_COMPARATOR

liagsure device

Intervention Type: 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

conventional thyroidectomy

with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imam Mohammad ibn Saud Islamic University

OTHER

Sponsor Role: lead

Responsible Party

mohammad bukhetan alharbi

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ligasure safety thyroidectomy

Identifier Type: -

Identifier Source: org_study_id