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Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

NCT03510923 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17380

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

  • Appendix
  • Appendectomy
  • Appendiceal Neoplasms
  • Gallbladder
  • Cholecystectomy
  • Gallbladder Neoplasms

Interventions

OTHER

Inspection and palpation of the appendix

The removed appendix will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The appendix will not be opened. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the appendix, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.

OTHER

Inspection and palpation of the gallbladder

The removed gallbladder will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The gallbladder is opened in its length, without cutting the cystic duct, and is inspected and palpated. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the gallbladder, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Willem Bemelman, Professor · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-02-01
Completion
2020-12-24

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510923 on ClinicalTrials.gov