Justification of Incidental Appendectomy With Respect to Pathohistological Findings

NCT05202600 | Unknown

• 1 other identifier: KOLO_2022_001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to justify performing an incidental appendectomy according to the following hypotheses:

1. 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. 2.The number needed to treat (NNT) for appendiceal tumors in the elderly is less than 500.
3. 3.The rate of complicated AA in the elderly population is significantly higher than in the younger age group
4. 4.NNT IA for complicated appendicitis in the elderly is less than 300.
5. 5.NNT IA for potential death due to AA in the elderly is less than 500.

Conditions

Appendix Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incidence of complicated appendicits

  01.01.2017. - 31.12.2021.

• NNT of IA for the complicated appendicits in elderly

  01.01.2017. - 31.12.2021.

• NNT of IA for the death due to appendicits in elderly

  01.01.2017. - 31.12.2021.

Other Outcomes (3)

• Size of the appendix as a predictor of neoplasm

  01.01.2017. - 31.12.2021.

• Definition of the elderly group for appendiceal neoplasm

  01.01.2017. - 31.12.2021.

• Definition of the elderly group for the complicated appendicitis or death

  01.01.2017. - 31.12.2021.

Study Arms (2)

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

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

Interventions

Appendectomy PROCEDURE

Surgical removal of the vermiform appendix.

Also known as: Appendicectomy

Acute appendectomy (AA); Incidental appendectomy (IA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital Split

Split, Split-Dalmatia County, 21000, Croatia

Location

Related Publications (8)

• 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.

  PMID: 32343238 RESULT

• 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.

  PMID: 28892212 RESULT

• 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.

  PMID: 19490638 RESULT

• 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.

  PMID: 29098385 RESULT

• 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.

  PMID: 30705736 RESULT

• 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.

  PMID: 12115365 RESULT

• 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.

  PMID: 25681217 RESULT

• 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.

  PMID: 32029830 RESULT

MeSH Terms

Conditions

Appendiceal Neoplasms

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ognjen Barcot, MD, PhD

  Department of surgery, University Hospital Split

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ognjen Barcot, MD, PhD

CONTACT

+385914344037; ognjen.barcot@gmail.com

Damir Quien, MD

CONTACT

+38521556420; kolo@kbsplit.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 21, 2022
• Study Start: February 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

CR (1)