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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
  1. Vivian P Bastiaenen1,
  2. Bartholomeus JGA Corten2,
  3. Elise AJ de Savornin Lohman3,
  4. Joske de Jonge4,
  5. Anne C Kraima1,
  6. Hilko A Swank1,
  7. Jaap LP van Vliet5,
  8. Gijs JD van Acker5,
  9. Anna AW van Geloven4,
  10. Klaas H in 't Hof6,
  11. Lianne Koens7,
  12. Philip R de Reuver3,
  13. Charles C van Rossem8,
  14. Gerrit D Slooter2,
  15. Pieter J Tanis1,
  16. Valeska Terpstra9,
  17. Marcel GW Dijkgraaf10,
  18. Willem A Bemelman1
  1. 1 Department of Surgery, Amsterdam UMC - Location AMC, Amsterdam, North Holland, Netherlands
  2. 2 Department of Surgery, Maxima Medical Centre - Location Veldhoven, Veldhoven, Noord-Brabant, Netherlands
  3. 3 Department of Surgery, Radboudumc, Nijmegen, Gelderland, Netherlands
  4. 4 Department of Surgery, Tergooi Hospitals, Hilversum, North Holland, Netherlands
  5. 5 Department of Surgery, Medical Centre Haaglanden, Den Haag, Zuid-Holland, Netherlands
  6. 6 Department of Surgery, Flevo Hospital, Almere, Flevoland, Netherlands
  7. 7 Department of Pathology, Amsterdam UMC - Location AMC, Amsterdam, North Holland, Netherlands
  8. 8 Department of Surgery, Maasstad Hospital, Rotterdam, Zuid-Holland, Netherlands
  9. 9 Department of Pathology, Medical Centre Haaglanden, Den Haag, Zuid-Holland, Netherlands
  10. 10 Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands
  1. Correspondence to Professor Willem A Bemelman; w.a.bemelman{at}amsterdamumc.nl

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number NCT03510923.

  • surgery
  • histopathology
  • health economics

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors VPB, MGWD and WAB have made substantial contributions to the conception and design of this study and have been involved in drafting the manuscript or revising it critically for important intellectual content. BJGAC has made substantial contributions to the design of this study and has been involved in drafting the manuscript. EAJdSL, JdJ, ACK, HAS, JLPvV, GJDvA, AAWvG, KHiH, LK, PRdR, CCvR, GDS, PJT and VT have made substantial contributions to the design of this study and the organisation of this trial and have revised the manuscript critically for important intellectual content. All authors have given final approval of the version to be published.

  • Funding This investigator initiated study was supported by the Netherlands Organisation for Health Research and Development (ZonMw) under grant number 843002822, of which the Dutch Ministry of Health, Welfare and Sports and the Dutch Organisation for Scientific Research are the main commissioning organisations. ZonMw has not played a role in designing the study and data collection, nor will it influence the analysis and writing process of the manuscripts.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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