Safety and cost analysis of selective histopathological examination following appendicectomy and cholecystectomy (FANCY study): protocol and statistical analysis plan of a prospective observational multicentre study.

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ID: 72816
2019
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Abstract
Routine histopathological examination following appendicectomy and cholecystectomy has significant financial implications and comprises a substantial portion of the pathologists' workload, while the incidence of unexpected pathology is low. The aim of the selective histopathological examination Following AppeNdicectomy and CholecystectomY (FANCY) study is to investigate the oncological safety and potential cost savings of selective histopathological examination based on macroscopic assessment performed by the surgeon.This is a Dutch multicentre prospective observational study, in which removed appendices and gallbladders will be systematically assessed by the operating surgeon for macroscopic abnormalities suspicious for malignant neoplasms. After visual inspection and digital palpation of the removed specimen, the operating surgeon will report whether macroscopic abnormalities suspicious for a malignant neoplasm are present, and if he or she believes additional microscopic examination by the pathologist is indicated. Regardless of the surgeon's assessment, all specimens will be sent for histopathological examination. In this way, routine histopathological examination can be compared with a hypothetical situation in which specimens are routinely examined by surgeons and only sent to the pathologist on indication. The two main outcomes are oncological safety and potential cost savings of a selective policy. Oncological safety of selective histopathological examination will be assessed by calculating the number of patients in whom a histopathological diagnosis of an appendiceal neoplasm or gallbladder cancer with clinical consequences benefitting the patient would have been missed. A cost analysis will be performed to quantify the potential cost savings.The study protocol was reviewed by the Institutional Review Board of the Amsterdam UMC, location AMC, which decided that the Dutch Medical Research Involving Human Subjects Act is not applicable. In all participating centres, approval for execution of the FANCY study has been obtained from the local Institutional Review Board before the start of inclusion of patients. The study results will be disseminated through peer-reviewed publications and conference presentations. Guidelines will be revised according to the findings of the study.NCT03510923.
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bastiaenen2019safetybmj Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Bastiaenen, Vivian P;Corten, Bartholomeus Jga;de Savornin Lohman, Elise Aj;de Jonge, Joske;Kraima, Anne C;Swank, Hilko A;van Vliet, Jaap Lp;van Acker, Gijs Jd;van Geloven, Anna Aw;In 't Hof, Klaas H;Koens, Lianne;de Reuver, Philip R;van Rossem, Charles C;Slooter, Gerrit D;Tanis, Pieter J;Terpstra, Valeska;Dijkgraaf, Marcel Gw;Bemelman, Willem A;
Journal BMJ open
Year 2019
DOI
10.1136/bmjopen-2019-035912
URL
Keywords
surgery health economics histopathology

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