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临床试验/NCT03510923
NCT03510923已完成不适用

Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy; the FANCY Study.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 17,380 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17,380
试验地点
1
主要终点
Costs

研究概览

简要总结

The FANCY study will investigate whether a selective policy of histopathological examination of appendices and gallbladders based on the intraoperative findings of the surgeon is safe and cost-effective.

详细描述

Traditionally, all surgically removed appendices and gallbladders are sent to the department of pathology for histopathological examination. This is most likely not necessary in appendices and gallbladders that are not suspicious for a tumour when inspected visually or by palpation. If not detected by visual inspection or palpation, the tumour is usually of early stage and already treated with the resection of the organ. A policy of selective histopathological examination based on the intraoperative findings of the surgeon can probably reduce the amount of appendices and gallbladders that have to be examined by the pathologist, without a risk of undertreatment, with less risk of overtreatment and huge savings annually. In the FANCY study, a nationwide prospective multicenter observational cohort study, all appendices and gallbladders will be evaluated for tumours by visual inspection and palpation by the operating surgeon. The operating surgeon will report his or her findings and also write down whether he or she thinks there is an indication for histopathological examination. Subsequently, all specimens are sent to the pathologist for histopathological examination. Therefore, no aberrant findings will be missed due to this study. The prospective cohort can be compared through modelling to a hypothetical situation where appendices and gallbladders are only examined by the pathologist on indication. The primary outcome is the number of patients per 1000 examined appendices/gallbladders with a neoplasm requiring additional therapy benefitting the patient that would have been unnoticed in the policy of selective histopathological examination.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients scheduled to undergo an appendectomy or cholecystectomy in the elective or non-elective setting.

排除标准

  • Primary indication for surgery: strong suspicion or proven malignancy in the appendix or gallbladder.
  • Appendix or gallbladder removed as part of more extensive surgery, so-called incidental appendectomies or cholecystectomies.
  • Patients included in the ACCURE trial (effect of appendectomy on ulcerative colitis).
  • The presence of a gallbladder polyp of >10 mm on preoperative imaging.

结局指标

主要结局

Costs

时间窗: 3 months

Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.

Unnoticed neoplasms requiring additional therapy benefitting the patient

时间窗: 3 months

Number of patients per 1000 examined appendices/gallbladders with a neoplasm requiring additional therapy benefitting the patient that would have been unnoticed in the policy of selective histopathological examination.

次要结局

  • Benefit of additional resection(2 weeks)
  • Harm of additional resection(1 month)
  • Other aberrant findings requiring additional therapy(3 months)
  • Malignancies(2 weeks)
  • Unnoticed malignancies(2 weeks)
  • Malignancies requiring more extensive resection or other additional treatment(3 months)
  • Other aberrant findings(2 weeks)

研究者

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

Willem A. Bemelman

Professor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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