Spots Global Cancer Trial Database for Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

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Trial Identification

Brief Title: Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

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

Study ID: NCT03510923

Conditions

Appendix

Appendectomy

Appendiceal Neoplasms

Gallbladder

Cholecystectomy

Gallbladder Neoplasms

Interventions

Inspection and palpation of the appendix

Inspection and palpation of the gallbladder

Study Description

Brief Summary: 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.

Detailed Description: 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.