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临床试验/NCT03514251
NCT03514251Unknown不适用

Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery

Bo Wang,MD1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
Calcium levels

研究概览

简要总结

To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery

详细描述

This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 with thyroid cancer who need central compartment dissection
  • Routine neck incision surgery
  • Patients undergoing primary neck surgery

排除标准

  • Benign thyroid tumor patients
  • Selecting patients with endoscopes, small incisions, or robotic surgery
  • Patients with hyperparathyroidism

研究组 & 干预措施

Control group

No Intervention

Routine thyroidectomy and central lymph node dissection

Parathyroid marker group

Experimental

When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker.

干预措施: The suture marks the location of the parathyroid gland (Procedure)

结局指标

主要结局

Calcium levels

时间窗: 0 days, 1 day, 2 weeks after surgery

Calcium level before and after surgery to detect

The stitch marking operation time

时间窗: During surgery

The time required for making a parathyroid marker by a suture method

Specimen inspection time

时间窗: During surgery

The time required for finding parathyroid glands in surgical specimens

The number of transplanted parathyroid glands

时间窗: When the surgery is completed

The number of parathyroid glands required for autotransplantation of parathyroid glands

Parathyroid hormone level testing

时间窗: 0 days, 1 day, 2 weeks after surgery

Parathyroid hormone levels before and after surgery

次要结局

未报告次要终点

研究者

发起方
Bo Wang,MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bo Wang,MD

Clinical Professor

Fujian Medical University

研究点 (1)

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