Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

NCT03510923 | Completed

• 1 other identifier: W17_328
• Study Type: observational
• Target: 17,380
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendix; Appendectomy; Appendiceal Neoplasms; Gallbladder; Cholecystectomy; Gallbladder Neoplasms

Keywords

Appendix; Appendectomy; Gallbladder; Cholecystectomy; Neoplasms; Pathology; Selective; Routine

Outcome Measures

Primary Outcomes (2)

• Unnoticed neoplasms requiring additional therapy benefitting the patient

  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.

  3 months

• Costs

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

  3 months

Secondary Outcomes (7)

• Malignancies

  2 weeks

• Unnoticed malignancies

  2 weeks

• Malignancies requiring more extensive resection or other additional treatment

  3 months

• Benefit of additional resection

  2 weeks

• Harm of additional resection

  1 month

Study Arms (2)

Patients who underwent an appendectomy

Patients of all ages who underwent an appendectomy in the elective or non-elective setting.

Other: Inspection and palpation of the appendix

Patients who underwent a cholecystectomy

Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting.

Other: Inspection and palpation of the gallbladder

Interventions

Inspection and palpation of the appendix OTHER

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.

Patients who underwent an appendectomy

Inspection and palpation of the gallbladder OTHER

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.

Patients who underwent a cholecystectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are scheduled to undergo an appendectomy or cholecystectomy in one of the participating centers in The Netherlands.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam-Zuidoost, 1105 AZ, Netherlands

Location

Related Publications (1)

• Bastiaenen VP, Corten BJ, de Savornin Lohman EA, de Jonge J, Kraima AC, Swank HA, van Vliet JL, van Acker GJ, van Geloven AA, In 't Hof KH, Koens L, de Reuver PR, van Rossem CC, Slooter GD, Tanis PJ, Terpstra V, Dijkgraaf MG, Bemelman WA. 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. BMJ Open. 2019 Dec 23;9(12):e035912. doi: 10.1136/bmjopen-2019-035912.

  PMID: 31874901 DERIVED

MeSH Terms

Conditions

Appendiceal Neoplasms; Gallbladder Neoplasms; Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Willem Bemelman, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 27, 2018
• Study Start: May 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: December 24, 2020
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

NL (1)