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UnknownNCT05202600

Justification of Incidental Appendectomy With Respect to Pathohistological Findings

Status
Unknown
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
University Hospital of Split · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREAppendectomySurgical removal of the vermiform appendix.

Timeline

Start date
2022-02-01
Primary completion
2022-04-01
Completion
2022-06-01
First posted
2022-01-21
Last updated
2022-01-21

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT05202600. Inclusion in this directory is not an endorsement.

Justification of Incidental Appendectomy With Respect to Pathohistological Findings (NCT05202600) · Clinical Trials Directory