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临床试验/NCT03615456
NCT03615456已完成不适用

Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Volume of postoperative drainage

研究概览

简要总结

This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:
  • Solitary thyroid nodule (STN)
  • Multinodular goiter
  • Controlled toxic goiter
  • Inflammatory goiter (thyroiditis)
  • Early-stage thyroid cancer.

排除标准

  • Patients unfit for surgery
  • patients unwilling to participate in the study
  • Pregnant women
  • Thyroid cancer with lymph node or distant metastasis.
  • Patients with psychiatric disturbances.

研究组 & 干预措施

Conventional thyroidectomy

Active Comparator

Thyroidectomy with ligation and division of thyroid vessels

干预措施: Conventional thyroidectomy (Procedure)

Harmonic scalpel thyroidectomy

Active Comparator

Thyroidectomy with sealing of thyroid vessels using harmonic scalpel

干预措施: Harmonic scalpel thyroidectomy (Procedure)

结局指标

主要结局

Volume of postoperative drainage

时间窗: At 24 hours after surgery

The volume of fluid drained in the suction drain placed in the neck in milliliters

次要结局

未报告次要终点

研究者

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

Sameh Emile

Assistant professor of surgery

Mansoura University

研究点 (2)

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