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
About this trial
This is an interventional treatment trial for Thyroid
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.
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
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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