Justification of Incidental Appendectomy With Respect to Pathohistological Findings

Appendix Tumor Clinical Trial

Official title:

Justification of Incidental Appendectomy With Respect to Pathohistological Findings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05202600
• Other study ID #: KOLO_2022_001
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2022
• Source: University Hospital of Split
• Contact: Ognjen Barcot, MD, PhD
• Phone: +385914344037
• Email: ognjen.barcot[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Appendiceal Neoplasms
• Appendix Tumor

Intervention

Procedure:
• Appendectomy
Surgical removal of the vermiform appendix.

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split	Splitsko-dalmatinska

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

References & Publications (8)

Ahmed HO, Muhedin R, Boujan A, Aziz AHS, Abdulla AM, Hardi RA, Abdulla AA, Sidiq TA. A five-year longitudinal observational study in morbidity and mortality of negative appendectomy in Sulaimani teaching Hospital/Kurdistan Region/Iraq. Sci Rep. 2020 Feb 6 — View Citation

Akbulut S, Koc C, Kocaaslan H, Gonultas F, Samdanci E, Yologlu S, Yilmaz S. Comparison of clinical and histopathological features of patients who underwent incidental or emergency appendectomy. World J Gastrointest Surg. 2019 Jan 27;11(1):19-26. doi: 10.4 — View Citation

Akbulut S, Koç C, Sarici B, Özcan M, Samdanci E, Yilmaz S. Histopathological features of incidental appendectomy specimens obtained from living liver donors. Turk J Gastroenterol. 2020 Mar;31(3):257-263. doi: 10.5152/tjg.2020.19010. — View Citation

Choksuwattanasakul M. Incidental appendectomy during mini incision post-partum sterilization (Chokchai technique): A prospective cross-sectional study. J Obstet Gynaecol Res. 2017 Dec;43(12):1863-1869. doi: 10.1111/jog.13458. Epub 2017 Sep 11. — View Citation

Hüttenbrink C, Hatiboglu G, Simpfendörfer T, Radtke JP, Becker R, Teber D, Hadaschik B, Pahernik S, Hohenfellner M. Incidental appendectomy during robotic laparoscopic prostatectomy-safe and worth to perform? Langenbecks Arch Surg. 2018 Mar;403(2):265-269 — View Citation

Lohsiriwat V, Vongjirad A, Lohsiriwat D. Incidence of synchronous appendiceal neoplasm in patients with colorectal cancer and its clinical significance. World J Surg Oncol. 2009 Jun 2;7:51. doi: 10.1186/1477-7819-7-51. — View Citation

McCusker ME, Coté TR, Clegg LX, Sobin LH. Primary malignant neoplasms of the appendix: a population-based study from the surveillance, epidemiology and end-results program, 1973-1998. Cancer. 2002 Jun 15;94(12):3307-12. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Size of the appendix as a predictor of neoplasm	Receiver operating curve analysis of the size of the vermiform appendix impacting the classification to neoplastic appendix	01.01.2017. - 31.12.2021.
Other	Definition of the elderly group for appendiceal neoplasm	Receiver operating curve analysis of the age of the patient impacting the classification to neoplastic appendix	01.01.2017. - 31.12.2021.
Other	Definition of the elderly group for the complicated appendicitis or death	Receiver operating curve analysis of the age of the patient impacting the classification to the complicated appendicitis or death	01.01.2017. - 31.12.2021.
Primary	Incidence of appendiceal neoplasms	Incidence of appendiceal neoplasms in IA which will be compared to the incidence of appendiceal neoplasms AA from respective PH samples.	01.01.2017. - 31.12.2021.
Primary	NNT of IA for the appendiceal neoplasm	The number of needed incidental appendectomies necessary to avoid one occurence of appendiceal neoplasm	01.01.2017. - 31.12.2021.
Secondary	Incidence of complicated appendicits	Comparison of incidences of complicated appendicits in young vs elderly	01.01.2017. - 31.12.2021.
Secondary	NNT of IA for the complicated appendicits in elderly	The number of needed incidental appendectomies necessary to avoid one occurence of complicated appendicitis in elderly	01.01.2017. - 31.12.2021.
Secondary	NNT of IA for the death due to appendicits in elderly	The number of needed incidental appendectomies necessary to avoid one death from complicated appendicitis in elderly	01.01.2017. - 31.12.2021.