Justification of Incidental Appendectomy With Respect to Pathohistological Findings

NCT ID: NCT05202600

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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

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Appendix Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Appendectomy

Intervention Type PROCEDURE

Surgical removal of the vermiform appendix.

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.

Appendectomy

Intervention Type PROCEDURE

Surgical removal of the vermiform appendix.

Interventions

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Appendectomy

Surgical removal of the vermiform appendix.

Intervention Type PROCEDURE

Other Intervention Names

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Appendicectomy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Split

OTHER

Sponsor Role lead

Responsible Party

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Ognjen Barcot

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ognjen Barcot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of surgery, University Hospital Split

Locations

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University Hospital Split

Split, Split-Dalmatia County, Croatia

Site Status

Countries

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Croatia

Central Contacts

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Ognjen Barcot, MD, PhD

Role: CONTACT

+385914344037

Damir Quien, MD

Role: CONTACT

+38521556420

Facility Contacts

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Ognjen Barcot, MD, PhD

Role: primary

0914344037

Damir Quien, MD

Role: backup

+38521556420

References

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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.

Reference Type RESULT
PMID: 32343238 (View on PubMed)

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.

Reference Type RESULT
PMID: 28892212 (View on PubMed)

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.

Reference Type RESULT
PMID: 19490638 (View on PubMed)

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.

Reference Type RESULT
PMID: 29098385 (View on PubMed)

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.

Reference Type RESULT
PMID: 30705736 (View on PubMed)

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.

Reference Type RESULT
PMID: 12115365 (View on PubMed)

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.

Reference Type RESULT
PMID: 25681217 (View on PubMed)

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.

Reference Type RESULT
PMID: 32029830 (View on PubMed)

Other Identifiers

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KOLO_2022_001

Identifier Type: -

Identifier Source: org_study_id

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