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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who underwent an appendectomy | Patients of all ages who underwent an appendectomy in the elective or non-elective setting. |
| |
| Patients who underwent a cholecystectomy | Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Malignancies | Incidence of malignancies in resected appendices and gallbladders | 2 weeks |
| Unnoticed malignancies | Incidence of unnoticed malignancies in resected appendices and gallbladders |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are scheduled to undergo an appendectomy or cholecystectomy in one of the participating centers in The Netherlands.
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| Name | Affiliation | Role |
|---|---|---|
| Willem Bemelman, Professor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam-Zuidoost | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31874901 | Derived | 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. |
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|
| 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. |
|
| 2 weeks |
| Malignancies requiring more extensive resection or other additional treatment | Incidence of malignancies in resected appendices and gallbladders that subsequently require more extensive resection or other additional treatment. | 3 months |
| Benefit of additional resection | Remaining tumour tissue and/or positive lymph nodes in re-resection specimen | 2 weeks |
| Harm of additional resection | Incidence of postoperative complications | 1 month |
| Other aberrant findings | Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms. | 2 weeks |
| Other aberrant findings requiring additional therapy | Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms that require additional therapy. | 3 months |
| ID | Term |
|---|---|
| D001063 | Appendiceal Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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