Justification of Incidental Appendectomy With Respect to Pathohistological Findings
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of appendiceal neoplasms
研究概览
简要总结
This study seeks to justify performing an incidental appendectomy according to the following hypotheses:
- 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)
- The number needed to treat (NNT) for appendiceal tumors in the elderly is less than 500.
- The rate of complicated AA in the elderly population is significantly higher than in the younger age group
- NNT IA for complicated appendicitis in the elderly is less than 300.
- NNT IA for potential death due to AA in the elderly is less than 500.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of appendiceal neoplasms
时间窗: 01.01.2017. - 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 neoplasm
时间窗: 01.01.2017. - 31.12.2021.
The number of needed incidental appendectomies necessary to avoid one occurence of appendiceal neoplasm
次要结局
- Incidence of complicated appendicits(01.01.2017. - 31.12.2021.)
- NNT of IA for the death due to appendicits in elderly(01.01.2017. - 31.12.2021.)
- NNT of IA for the complicated appendicits in elderly(01.01.2017. - 31.12.2021.)
研究者
Ognjen Barcot
Ass. Prof.
University Hospital of Split