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Clinical Trials/NCT04108923
NCT04108923
Unknown
Not Applicable

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

Assiut University0 sites80 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Diseases
Sponsor
Assiut University
Enrollment
80
Primary Endpoint
Post-operative complications
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
April 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abadeer Raafat Marsis Rizallah

Resident doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study

Exclusion Criteria

  • patient undergoing re-do surgery " completion thyroidectomy "
  • patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

Outcomes

Primary Outcomes

Post-operative complications

Time Frame: Postoperatively from day of surgery until one week post operatively

Including RLN palsy , hypocalcemia , hemorrhage wound infection

Intraoperative blood loss

Time Frame: 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 "

Post-operative blood loss

Time Frame: From skin closure until one week post operatively

Measuring postoperative blood loss by measuring contents of drains

Operation time

Time Frame: Baseline

From skin incision to skin closure

Secondary Outcomes

  • Length of hospital stay(Baseline up to two weeks)

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