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Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

Primary Purpose

Thyroid Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ligasure
Conventional vessel ligation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Diseases focused on measuring Thyroidectomy, Ligasure, Vessel ligation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

    Active Comparator

    Arm Label

    Ligasure ( group A)

    Conventional vessel ligation (group B)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Intraoperative blood loss
    Measuring intraoperative blood loss using surgical towels and contents of suction. Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "
    Post-operative blood loss
    Measuring postoperative blood loss by measuring contents of drains
    Post-operative complications
    Including RLN palsy , hypocalcemia , hemorrhage wound infection
    Operation time
    From skin incision to skin closure

    Secondary Outcome Measures

    Length of hospital stay
    Measuring number of days of patient stay in hospital to be pain- free return to activity and work. From day of surgery until discharge

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    January 6, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04108923
    Brief Title
    Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy
    Official Title
    Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy " Randomised Controlled Study"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    April 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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 between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate
    Detailed Description
    The significant vascularity of the thyroid gland and the relatively small operative field makes meticulous hemostasis an important prerequisite in thyroid surgery for successful outcome. The mainstay for achieving hemostasis in thyroidectomy is tying and / or clipping of blood vessels. New technologies have been introduced , among them the vessel sealing device ( ligasure ) which seals vessels by fusing the inner layers of the vessel wall with minimal levels of thermal dispersion burning and tissue friction thereby reducing incidence of accidental burns . This study is designed to evaluate the safety and efficacy of using ligasure compared with conventional vessel ligation in open thyroid surgery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Diseases
    Keywords
    Thyroidectomy, Ligasure, Vessel ligation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ligasure ( group A)
    Arm Type
    Active Comparator
    Arm Title
    Conventional vessel ligation (group B)
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Ligasure
    Intervention Description
    the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional vessel ligation
    Intervention Description
    Conventional vessel ligation either tying and /or clipping of blood vessels
    Primary Outcome Measure Information:
    Title
    Intraoperative blood loss
    Description
    Measuring intraoperative blood loss using surgical towels and contents of suction. Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "
    Time Frame
    Baseline
    Title
    Post-operative blood loss
    Description
    Measuring postoperative blood loss by measuring contents of drains
    Time Frame
    From skin closure until one week post operatively
    Title
    Post-operative complications
    Description
    Including RLN palsy , hypocalcemia , hemorrhage wound infection
    Time Frame
    Postoperatively from day of surgery until one week post operatively
    Title
    Operation time
    Description
    From skin incision to skin closure
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Length of hospital stay
    Description
    Measuring number of days of patient stay in hospital to be pain- free return to activity and work. From day of surgery until discharge
    Time Frame
    Baseline up to two weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abadeer Rizallah
    Phone
    +201289028410
    Email
    dr.abadeermarsis@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18585113
    Citation
    Youssef T, Mahdy T, Farid M, Latif AA. Thyroid surgery: use of the LigaSure Vessel Sealing System versus conventional knot tying. Int J Surg. 2008 Aug;6(4):323-7. doi: 10.1016/j.ijsu.2008.05.005. Epub 2008 May 23.
    Results Reference
    background
    PubMed Identifier
    27565244
    Citation
    Vidal O, Saavedra-Perez D, Valentini M, Astudillo E, Fernandez-Cruz L, Garcia-Valdecasas JC. Surgical outcomes of total thyroidectomy using the LigaSure Small Jaw versus LigaSure Precise: A retrospective study of 2000 consecutive patients. Int J Surg. 2017 Jan;37:8-12. doi: 10.1016/j.ijsu.2016.08.241. Epub 2016 Aug 23.
    Results Reference
    background
    PubMed Identifier
    27481528
    Citation
    Luo Y, Li X, Dong J, Sun W. A comparison of surgical outcomes and complications between hemostatic devices for thyroid surgery: a network meta-analysis. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1269-1278. doi: 10.1007/s00405-016-4190-3. Epub 2016 Aug 1.
    Results Reference
    background
    PubMed Identifier
    25536733
    Citation
    Peker K, Dumanli Ozcan AT, Sahin M, Inal A, Kilic K, Ozcicek F. A comparison of total thyroidectomies carried out through LigaSure and Harmonic Scalpel: a retrospective study. Turk J Med Sci. 2014;44(2):255-60. doi: 10.3906/sag-1210-94.
    Results Reference
    background

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    Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

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