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Justification of Incidental Appendectomy With Respect to Pathohistological Findings

Justification of Incidental Appendectomy With Respect to Pathohistological Findings

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05202600
Enrollment
1000
Registered
2022-01-21
Start date
2022-02-01
Completion date
2022-06-01
Last updated
2022-01-21

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

Conditions

Appendix Tumor

Brief summary

This study seeks to justify performing an incidental appendectomy according to the following hypotheses: 1. The frequency of neoplasms in pathohistological (PHD) findings of incidental appendectomy (IA) is significantly higher than in PHD findings in appendectomies for acute appendcitis (AA) 2. The number needed to treat (NNT) for appendiceal tumors in the elderly is less than 500. 3. The rate of complicated AA in the elderly population is significantly higher than in the younger age group 4. NNT IA for complicated appendicitis in the elderly is less than 300. 5. NNT IA for potential death due to AA in the elderly is less than 500.

Detailed description

A retrospective cross-sectional study will be done. The archive of all PHD findings will be searched, and then the relevant medical histories at the Clinic of Surgery, University Hospital Center Split in the period from 01.01.2017. to 31.12.2021. The data collection will be done in the period from 01.02.2022. to 31.03.2022. The data collection (extraction) will be done by the main researcher (graduate, Ante Tavra) with at least two other colleagues from the Department of Abdominal-Coloproctological Surgery, University Hospital Center Split (Damir Quien, MD and Dora Bjelanović, MD). Data will be collected directly from medical history and entered into an overview table. The identity of the respondents will remain secret, and the respondents will be marked exclusively with an identification number. This type of research does not require the informed consent of the patient, and all data collected will be kept in accordance with the provisions of Annex 2 of the Application to Institutional advisory board of UHC Split (approval pending).

Interventions

PROCEDUREAppendectomy

Surgical removal of the vermiform appendix.

Sponsors

University Hospital of Split
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients operated for colon tumors who have data on age, sex, data on a previously diagnosed colon tumor, data on incidental appendectomy, and a PHD finding for a removed appendix. Adult patients who have been diagnosed with acute appendicitis and have data on age, sex, data on the diagnosis of acute appendicitis and accompanying PHD findings, newly performed appendectomies.

Exclusion criteria

We will exclude from the analysis patients who had previous appendectomy, appendectomy has not been performed or we do not have an accompanying PHD finding of the appendix, and patients younger than 18 years.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of appendiceal neoplasms01.01.2017. - 31.12.2021.Incidence of appendiceal neoplasms in IA which will be compared to the incidence of appendiceal neoplasms AA from respective PH samples.
NNT of IA for the appendiceal neoplasm01.01.2017. - 31.12.2021.The number of needed incidental appendectomies necessary to avoid one occurence of appendiceal neoplasm

Secondary

MeasureTime frameDescription
NNT of IA for the complicated appendicits in elderly01.01.2017. - 31.12.2021.The number of needed incidental appendectomies necessary to avoid one occurence of complicated appendicitis in elderly
Incidence of complicated appendicits01.01.2017. - 31.12.2021.Comparison of incidences of complicated appendicits in young vs elderly
NNT of IA for the death due to appendicits in elderly01.01.2017. - 31.12.2021.The number of needed incidental appendectomies necessary to avoid one death from complicated appendicitis in elderly

Other

MeasureTime frameDescription
Definition of the elderly group for appendiceal neoplasm01.01.2017. - 31.12.2021.Receiver operating curve analysis of the age of the patient impacting the classification to neoplastic appendix
Definition of the elderly group for the complicated appendicitis or death01.01.2017. - 31.12.2021.Receiver operating curve analysis of the age of the patient impacting the classification to the complicated appendicitis or death
Size of the appendix as a predictor of neoplasm01.01.2017. - 31.12.2021.Receiver operating curve analysis of the size of the vermiform appendix impacting the classification to neoplastic appendix

Countries

Croatia

Contacts

Primary ContactOgnjen Barcot, MD, PhD
ognjen.barcot@gmail.com+385914344037
Backup ContactDamir Quien, MD
kolo@kbsplit.hr+38521556420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026