A Novel Appendicitis TriMOdal Prediction Score (ATMOS) for Acute Appendicitis in Pregnancy: a Retrospective Observational Study (ATMOS)

August 9, 2022 updated by: Branko Bogdanic, Clinical Hospital Centre Zagreb
Acute appendicitis (AA) is a disease of younger age, but it occurs in 1 out of 500-2000 pregnancies. The current treatment of choice for AA in pregnancy is surgical. Even with standard clinical examination, serum inflammatory markers, and transabdominal ultrasound, the decision on surgical treatment of acute appendicitis (AA) and the rate of negative appendectomy in pregnancy are still unsatisfactory. There are several scoring systems (Alvarado, Tzanakis) that help making decision on operating more easier, however their specificity is either high with low sensitivity, or the other way around. In addition, all scores are based on adult non-pregnant population. We are making an observational study to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.

Study Overview

Status

Completed

Conditions

Detailed Description

The study includes extraction of medical data for pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of AA, from January 2010 to December 2020. The aim of this study is to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients (pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of acute appendicitis, from January 2010 to December 2020.) demographics, symptoms, laboratory findings, diagnostic and treatment modalities were extracted from electronic medical records.

Description

Inclusion Criteria:

  • pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of acute appendicitis, from January 2010 to December 2020.

Exclusion Criteria:

  • non-pregnant patients
  • pregnant patients younger than 18 years
  • diagnosis made with CT or MRI
  • pregnant patients with the acute abdomen (intraoperative diffuse peritonitis) from acute appendicitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors of acute appendicitis in pregnancy
Time Frame: January 2010 to December 2020
Detection of predictive factors of acute appendicitis in pregnancy
January 2010 to December 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Centre Zagreb

Collaborators

Goran Augustin
Ognjen Barcot
Mislav Herman
Salvatore Giovanni Vitale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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