Clinical trial NCT05202600: Justification of Incidental Appendectomy With Respect to Pathohistological Findings
Official title: Justification of Incidental Appendectomy With Respect to Pathohistological Findings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appendix Tumor
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients operated in UHC Split Surgery Clinic for colon cancer or acute appendicitis during 5-year period.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of appendiceal neoplasms
timeFrame: 01.01.2017. - 31.12.2021.
measure: NNT of IA for the appendiceal neoplasm
timeFrame: 01.01.2017. - 31.12.2021.
Secondary outcomes:
measure: Incidence of complicated appendicits
timeFrame: 01.01.2017. - 31.12.2021.
measure: NNT of IA for the complicated appendicits in elderly
timeFrame: 01.01.2017. - 31.12.2021.
measure: NNT of IA for the death due to appendicits in elderly
timeFrame: 01.01.2017. - 31.12.2021.
Other outcomes:
measure: Size of the appendix as a predictor of neoplasm
timeFrame: 01.01.2017. - 31.12.2021.
measure: Definition of the elderly group for appendiceal neoplasm
timeFrame: 01.01.2017. - 31.12.2021.
measure: Definition of the elderly group for the complicated appendicitis or death
timeFrame: 01.01.2017. - 31.12.2021.
Locations:
city: Split
country: Croatia
facility: University Hospital Split
state: Splitsko-dalmatinska
Study officials:
affiliation: Department of surgery, University Hospital Split
name: Ognjen Barcot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Segev L, Keidar A, Schrier I, Rayman S, Wasserberg N, Sadot E. Acute appendicitis in the elderly in the twenty-first century. J Gastrointest Surg. 2015 Apr;19(4):730-5. doi: 10.1007/s11605-014-2716-9. Epub 2015 Feb 14.
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