Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

Study Overview
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Brief Summary
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To compare between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate

Detailed Description
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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

Official Title
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Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy  Randomised Controlled Study

Conditions
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Thyroid Diseases

Intervention / Treatment
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* Device: Ligasure
* Procedure: Conventional vessel ligation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligasure ( group A)<br> | Device: Ligasure<br>* the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall<br>|
| Active Comparator: Conventional vessel ligation (group B)<br> | Procedure: Conventional vessel ligation<br>* Conventional vessel ligation either tying and /or clipping of blood vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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  | Baseline | 
| Post-operative blood loss | Measuring postoperative blood loss by measuring contents of drains | From skin closure until one week post operatively | 
| Post-operative complications | Including RLN palsy , hypocalcemia , hemorrhage wound infection | Postoperatively from day of surgery until one week post operatively | 
| Operation time | From skin incision to skin closure | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline up to two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Ligasure, Vessel ligation