Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

Not Applicable

• Conditions: Thyroid Diseases
• Interventions: Procedure: Conventional vessel ligation; Device: Ligasure

• Registration Number: NCT04108923
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07
• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional vessel ligation (group B)	Conventional vessel ligation	-
Ligasure ( group A)	Ligasure	-

Primary Outcome Measures

Name	Time	Method
Post-operative blood loss	From skin closure until one week post operatively	Measuring postoperative blood loss by measuring contents of drains
Post-operative complications	Postoperatively from day of surgery until one week post operatively	Including RLN palsy , hypocalcemia , hemorrhage wound infection
Intraoperative blood loss	Baseline	Measuring intraoperative blood loss using surgical towels and contents of suction.; Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "
Operation time	Baseline	From skin incision to skin closure

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Baseline up to two weeks	Measuring number of days of patient stay in hospital to be pain- free return to activity and work.; From day of surgery until discharge