Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

Assiut University

Status: Unknown

Conditions: Thyroid Diseases

Treatments: Procedure: Conventional vessel ligation; Device: Ligasure

Study type: Interventional

Funder types: Other

Identifiers

NCT04108923

Hemostasis in thyroidectomy

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Ligasure ( group A)

Active Comparator group

Treatment:

Device: Ligasure

Conventional vessel ligation (group B)

Active Comparator group

Treatment:

Procedure: Conventional vessel ligation