跳至主要内容
临床试验/NCT07274891
NCT07274891尚未招募不适用

Comparative Evaluation of LigaSure Versus Bipolar Diathermy in Thyroidectomy: A Single-Center Study From Upper Egyp

Assiut University0 个研究点目标入组 30 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Operative time

研究概览

简要总结

Comparative Evaluation of LigaSure Versus Conventional Bipolar Diathermy in Thyroid Surgery: Operative and Postoperative Outcome.

详细描述

Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders. Achieving precise hemostasis is essential to minimize intraoperative bleeding, preserve vital structures such as the recurrent laryngeal nerve and parathyroid glands, and prevent complications like hematoma and infection. Conventional bipolar diathermy has long been used to achieve hemostasis, but it can result in greater lateral thermal spread, prolonged operative time, and potential thermal injury to adjacent tissues.

LigaSure, an advanced vessel sealing system, combines pressure and energy to achieve permanent vessel fusion and can seal vessels up to 7 mm in diameter with minimal lateral thermal damage. Its use in thyroid surgery has been associated with improved surgical field visibility, reduced intraoperative bleeding, and shorter operative time compared to bipolar diathermy.

Additionally, LigaSure may lower the risk of postoperative complications, including transient hypocalcemia and recurrent laryngeal nerve palsy, due to its precise energy delivery and limited collateral damage.

However, existing studies have shown variable results regarding the magnitude of these benefits, and the cost-effectiveness of LigaSure compared with conventional bipolar diathermy remains uncertain. Therefore, a prospective randomized controlled trial is required to provide conclusive evidence regarding its role in reducing operative time and postoperative complications during thyroidectomy.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years) undergoing partial or total thyroidectomy.
  • Diagnosed with benign or low-risk malignant thyroid disorders.
  • Fit for general anesthesia.
  • Provided written informed consent to participate in the study.

排除标准

  • 1.Previous neck surgery or radiotherapy.

结局指标

主要结局

Operative time

时间窗: during surgery 2 hours

Total time (from skin to skin)Time taken for dissection and haemostasis

Number of ligatures used

时间窗: during surgery

Number of ligatures used

时间窗: during surgery

Operative time

时间窗: during surgery 2 hours

Total time (from skin to skin)Time taken for dissection and haemostasis

次要结局

  • Postoperative pain(24 hours postoperative)
  • Transient or permanent hypocalcaemia(24 hours postoperative)
  • Postoperative pain(24 hours postoperative)
  • Transient or permanent hypocalcaemia(24 hours postoperative)

研究者

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

Keroles Atef Shaffik Nassem

Doctor

Assiut University

相似试验