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Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

Primary Purpose

Ligature; Hemorrhage, Recurrent Laryngeal Nerve Injuries, Hypocalcemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
liagsure device
Sponsored by
Imam Mohammad ibn Saud Islamic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ligature; Hemorrhage

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    ligasure throidectomy

    conventional thyroidectomy

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    Post-operative complications
    Including RLN palsy , hypocalcemia , hemorrhage wound infection

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2023
    Last Updated
    January 5, 2023
    Sponsor
    Imam Mohammad ibn Saud Islamic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05684536
    Brief Title
    Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
    Official Title
    Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imam Mohammad ibn Saud Islamic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ligature; Hemorrhage, Recurrent Laryngeal Nerve Injuries, Hypocalcemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ligasure throidectomy
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    conventional thyroidectomy
    Arm Type
    No Intervention
    Arm Description
    with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips
    Intervention Type
    Device
    Intervention Name(s)
    liagsure device
    Intervention Description
    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 Measure Information:
    Title
    Post-operative complications
    Description
    Including RLN palsy , hypocalcemia , hemorrhage wound infection
    Time Frame
    Postoperatively from day of surgery until one week post operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

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