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Safety and cost-effectiveness of selective histopathological examination of appendices and gallbladders

Selective rather than routine histopathological examination after appendectomy and cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23801
Enrollment
8924
Registered
2018-04-16
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendix, Appendectomy, Gallbladder, Cholecystectomy, Pathology, Histopathological examination, Selective, Routine. Appendix, Appendectomie, Galblaas, Cholecystectomie, Pathologie, Histopathologisch onderzoek, Selectief, Routinematig.

Interventions

All appendices and gallbladders will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The appendix will not be opened. Particularly the top
pre- and intraoperative data will be processed after surgery, and the postoperative outcomes when the pathology report is available (± 2 weeks after surgery). Pre- and postoperative data will be obtai

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of all ages who are scheduled to undergo an appendectomy or cholecystectomy in the elective or non-elective setting.

Exclusion criteria

Exclusion criteria: Appendix: - Primary indication for surgery: strong suspicion or proven malignancy in the appendix. - Appendix removed as part of more extensive surgery, a so-called incidental appendectomy. - Patients included in the ACCURE trial. Gallbladder: - Primary indication for surgery: strong suspicion of malignancy in the gallbladder. - Gallbladder removed as part of more extensive surgery, a so-called incidental cholecystectomy. - The presence of a polyp of >10 mm on preoperative imaging.

Design outcomes

Primary

MeasureTime frame
1. 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. 2. Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.

Secondary

MeasureTime frame
1. Incidence of malignancies in resected appendices and gallbladders. 2. Incidence of unnoticed malignancies in resected appendices and gallbladders. 3. Incidence of malignancies in resected appendices and gallbladders that subsequently require more extensive resection or other additional treatment. 4. Clinical consequences of more extensive resection or other additional treatment in patients with a malignancy found at histopathological examination of the appendix or gall bladder. a. Remaining tumour tissue and/or positive lymph nodes in re-resection specimen b. Postoperative complications These secondary outcomes will also be reported for other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.

Contacts

Public ContactV.P. (Vivian) Bastiaenen

Academisch Medisch Centrum, Afdeling Chirurgie, kamer G4-134

v.p.bastiaenen@amc.nl+31 20 566 5199

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)