Justification of Incidental Appendectomy With Respect to Pathohistological Findings

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Appendix Tumor
• Intervention / Treatment: Procedure: Appendectomy

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).

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ognjen Barcot, MD, PhD; Phone Number: +385914344037; Email: ognjen.barcot@gmail.com
• Study Contact Backup: Name: Damir Quien, MD; Phone Number: +38521556420; Email: kolo@kbsplit.hr

Study Locations

• Croatia
  • Splitsko-dalmatinska
    • Split, Splitsko-dalmatinska, Croatia, 21000
      • University Hospital Split
      • Contact: Damir Quien, MD; Phone Number: +38521556420; Email: kolo@kbsplit.hr
      • Contact: Ognjen Barcot, MD, PhD; Phone Number: 0914344037; Email: ognjen.barcot@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Incidental appendectomy (IA); 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.	Procedure: Appendectomy; Surgical removal of the vermiform appendix.; Other Names: Appendicectomy
Acute appendectomy (AA); 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.	Procedure: Appendectomy; Surgical removal of the vermiform appendix.; Other Names: Appendicectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complicated appendicits	Comparison of incidences of complicated appendicits in young vs elderly	01.01.2017. - 31.12.2021.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital of Split
• Investigators: Principal Investigator: Ognjen Barcot, MD, PhD, Department of surgery, University Hospital Split

Publications and helpful links

General Publications

• Akbulut S, Koc C, Sarici B, Ozcan 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.
• 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.
• 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.
• Huttenbrink C, Hatiboglu G, Simpfendorfer 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. doi: 10.1007/s00423-017-1630-5. Epub 2017 Nov 2.
• 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: 10.4240/wjgs.v11.i1.19.
• McCusker ME, Cote 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. doi: 10.1002/cncr.10589.
• 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.
• 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;10(1):2028. doi: 10.1038/s41598-020-58847-1.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Cecal Diseases; Cecal Neoplasms; Appendiceal Neoplasms
• Other Study ID Numbers: KOLO_2022_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data will be available upon reasonable request by the corresponding author (Ognjen Barcot).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No