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Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

Primary Purpose

Thyroid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid

Eligibility Criteria

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

Inclusion Criteria:

  • • Patient with disburbed thyroid function and candidate for for thyroidectomy

Exclusion Criteria:

  • Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Patients will do throidectomy using diathermy

    Patients will do thyroidectomy using ligasure .

    Arm Description

    In these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy .

    In these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure.

    Outcomes

    Primary Outcome Measures

    Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy
    This study is aiming to make a comparison between the incidence of intraoperative and postoperative bleeding while using diathermy versus using ligasure in homeostasis during thyroidectomy. The investigators will do their best to answer this question... 1. ls rate of postoperative complications decrease while using the ligasure than using traditional diathermy ?

    Secondary Outcome Measures

    Full Information

    First Posted
    September 17, 2022
    Last Updated
    October 1, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05567432
    Brief Title
    Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
    Official Title
    Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres. Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.
    Detailed Description
    Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection . Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    In about 20 participants , the investigators will control bleeding and cut tissues and blood vessels using the diathermy and in the other 20 , investigators will do homeostasis with ligasure.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients will do throidectomy using diathermy
    Arm Type
    Active Comparator
    Arm Description
    In these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy .
    Arm Title
    Patients will do thyroidectomy using ligasure .
    Arm Type
    Active Comparator
    Arm Description
    In these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure.
    Intervention Type
    Procedure
    Intervention Name(s)
    thyroidectomy
    Intervention Description
    use diathermy or ligasure for homeostatic during thyroidectomy
    Primary Outcome Measure Information:
    Title
    Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy
    Description
    This study is aiming to make a comparison between the incidence of intraoperative and postoperative bleeding while using diathermy versus using ligasure in homeostasis during thyroidectomy. The investigators will do their best to answer this question... 1. ls rate of postoperative complications decrease while using the ligasure than using traditional diathermy ?
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Patient with disburbed thyroid function and candidate for for thyroidectomy Exclusion Criteria: Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Aboelhassan, Master
    Phone
    00201024529525
    Email
    mahmoudaboelhassen37@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa Ibrahem, PHD
    Phone
    00201095295794
    Email
    Mostafamahmoud5622@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Korany, PHD
    Organizational Affiliation
    Assut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18082542
    Citation
    Manouras A, Markogiannakis H, Koutras AS, Antonakis PT, Drimousis P, Lagoudianakis EE, Kekis P, Genetzakis M, Koutsoumanis K, Bramis I. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg. 2008 Jan;195(1):48-52. doi: 10.1016/j.amjsurg.2007.01.037.
    Results Reference
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    Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

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