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Appendix TumorNCT05202600

Justification of Incidental Appendectomy With Respect to Pathohistological Findings

An observational study of Appendix Tumor, run by University Hospital of Split at 1 site in Croatia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Appendix Tumor
What is being tested?
Appendectomy
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 siteCroatia
Study dates
1 Feb 2022to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All the patients operated in UHC Split Surgery Clinic for colon cancer or acute appendicitis during 5-year period.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ognjen Barcot, MD, PhD contact

+385914344037

ognjen.barcot@gmail.com

Damir Quien, MD contact

+38521556420

kolo@kbsplit.hr

Croatia1 site

  • University Hospital Split

    Split, Split-Dalmatia County, 21000

    Ognjen Barcot, MD, PhD, 0914344037, ognjen.barcot@gmail.com

    Damir Quien, MD, +38521556420, kolo@kbsplit.hr

Other trials in Croatia

About this study

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.
Read the 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).

Conditions
Appendix Tumor
Being tested
Appendectomy
Medical subject headings
Appendiceal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AppendectomyProcedure or surgery

    Also called Appendicectomy

    Surgical removal of the vermiform appendix.

Study groups in NCT05202600
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Procedure: Appendectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 01.01.2017. - 31.12.2021.

  2. NNT of IA for the appendiceal neoplasm

    The number of needed incidental appendectomies necessary to avoid one occurence of appendiceal neoplasm

    Measured: 01.01.2017. - 31.12.2021.

Secondary outcomes (3)

  1. Incidence of complicated appendicits

    Comparison of incidences of complicated appendicits in young vs elderly

    Measured: 01.01.2017. - 31.12.2021.

  2. 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

    Measured: 01.01.2017. - 31.12.2021.

  3. 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

    Measured: 01.01.2017. - 31.12.2021.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start1 Feb 2022 (estimated)
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05202600
Sponsor's protocol ID
KOLO_2022_001
Status last verified
Jan 2022
First submitted
11 Jan 2022
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data will be available upon reasonable request by the corresponding author (Ognjen Barcot).

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.

    PubMed 32343238

  • 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.

    PubMed 28892212

  • 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.

    PubMed 19490638

  • 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.

    PubMed 29098385

  • 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.

    PubMed 30705736

  • 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.

    PubMed 12115365

  • 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.

    PubMed 25681217

  • 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.

    PubMed 32029830

Questions about this trial

What is this clinical trial studying?

An observational study of Appendix Tumor, run by University Hospital of Split at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ognjen Barcot, MD, PhD (+385914344037, ognjen.barcot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of appendiceal neoplasms (time frame: 01.01.2017. - 31.12.2021.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05202600, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.

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