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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05684536
Other study ID # ligasure safety thyroidectomy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date April 1, 2023

Study information

Verified date January 2023
Source Imam Mohammad ibn Saud Islamic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date April 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Imam Mohammad ibn Saud Islamic University

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative complications Including RLN palsy , hypocalcemia , hemorrhage wound infection Postoperatively from day of surgery until one week post operatively
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