跳至主要内容
临床试验/NCT04108923
NCT04108923Unknown不适用

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

Assiut University0 个研究点目标入组 80 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Post-operative complications

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Post-operative complications

时间窗: Postoperatively from day of surgery until one week post operatively

Including RLN palsy , hypocalcemia , hemorrhage wound infection

Intraoperative blood loss

时间窗: 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

时间窗: From skin closure until one week post operatively

Measuring postoperative blood loss by measuring contents of drains

Operation time

时间窗: Baseline

From skin incision to skin closure

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abadeer Raafat Marsis Rizallah

Resident doctor

Assiut University

相似试验