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Justification of Incidental Appendectomy With Respect to Pathohistological Findings

U

University Hospital of Split

Status

Unknown

Conditions

Appendix Tumor

Treatments

Procedure: Appendectomy

Study type

Observational

Funder types

Other

Identifiers

NCT05202600
KOLO_2022_001

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Incidental appendectomy (IA)
Description:
Group IA will include adult patients operated on 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 vermiform appendix.
Treatment:
Procedure: Appendectomy
Acute appendectomy (AA)
Description:
Group AA will include adult patients who have been operated due to clinical suspicion of acute appendicitis and have data on age, sex, data on the diagnosis of acute appendicitis and accompanying PHD findings of the performed appendectomy.
Treatment:
Procedure: Appendectomy

Trial contacts and locations

1

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Central trial contact

Ognjen Barcot, MD, PhD; Damir Quien, MD

Data sourced from clinicaltrials.gov

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