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临床试验/NCT02654873
NCT02654873已完成不适用

Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

Sisli Hamidiye Etfal Training and Research Hospital6 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
6
主要终点
The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases

研究概览

简要总结

Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.

详细描述

Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has cholelithiasis

排除标准

  • Subject has acute cholecystitis
  • Subject has perforated gallbladder
  • Subject has malignancy
  • Subject has polyps in the gallbladder
  • Subject has increasing wall thickness of the gallbladder
  • Subject has malignancy in the preoperative ultrasonography in the gallbladder
  • Subject has pregnancy

结局指标

主要结局

The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases

时间窗: 15 days

The 1000 cholecystectomy specimens will be evaluated macroscopically by two experienced surgeons with a longitudinal incision to the gallbladder. The specimens will be grouped as benign, suspicious, malign according to the surgeon's decision. To confirm the surgeon's macroscopic evaluation, all of the specimens will be evaluated histopathologically. The results of macroscopic and histopathological examinations will be compared.

次要结局

未报告次要终点

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ufuk Oguz Idiz

M.D.

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (6)

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