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

NCT ID: NCT05202483

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2021-12-20

Brief Summary

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.

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.

Conditions

Appendicitis in Pregnancy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Goran Augustin

UNKNOWN

Sponsor Role: collaborator

Ognjen Barcot

UNKNOWN

Sponsor Role: collaborator

Mislav Herman

UNKNOWN

Sponsor Role: collaborator

Salvatore Giovanni Vitale

UNKNOWN

Sponsor Role: collaborator

Clinical Hospital Centre Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Branko Bogdanic

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Center Zagreb

Zagreb, , Croatia

Countries

Croatia

References

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Reference Type: BACKGROUND

PMID: 32129808 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 32295644 (View on PubMed)

Augustin G, Boric M, Barcot O, Puljak L. Discordant outcomes of laparoscopic versus open appendectomy for suspected appendicitis during pregnancy in published meta-analyses: an overview of systematic reviews. Surg Endosc. 2020 Oct;34(10):4245-4256. doi: 10.1007/s00464-020-07674-6. Epub 2020 Jun 16.

Reference Type: BACKGROUND

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Yang J, Wen SW, Krewski D, Corsi DJ, Walker M, Mattison D, Moog R, McNair D, Huang H, Zhuang G. Association of treatments for acute appendicitis with pregnancy outcomes in the United States from 2000 to 2016: Results from a multi-level analysis. PLoS One. 2021 Dec 13;16(12):e0260991. doi: 10.1371/journal.pone.0260991. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34898628 (View on PubMed)

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Reference Type: BACKGROUND

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Sigdel GS, Lakhey PJ, Mishra PR. Tzanakis score vs. Alvarado score in acute appendicitis. JNMA J Nepal Med Assoc. 2010 Apr-Jun;49(178):96-9.

Reference Type: BACKGROUND

PMID: 21485591 (View on PubMed)

Augustin G, Mikus M, Bogdanic B, Barcot O, Herman M, Goldstajn MS, Tropea A, Vitale SG. A novel Appendicitis TriMOdal prediction Score (ATMOS) for acute appendicitis in pregnancy: a retrospective observational study. Updates Surg. 2022 Dec;74(6):1933-1941. doi: 10.1007/s13304-022-01368-5. Epub 2022 Sep 1.

Reference Type: DERIVED

PMID: 36048362 (View on PubMed)

Other Identifiers

202101

Identifier Type: -

Identifier Source: org_study_id