Validation and Comparison of the Appendicitis Inflammatory Response Score and Adult Appendicitis Score

Acute Appendicitis Clinical Trial

Official title:

Prospective Clinical Trial on Validation and Comparison of the Diagnostic and Prognostic Value of Appendicitis Inflammatory Response Score and Adult Appendicitis Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730752
• Other study ID #: 2021/07
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: May 25, 2021

Study information

• Verified date: May 2021
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute appendicitis is one of the most frequent reasons of emergency laparotomy in adults. Symptoms of acute appendicitis overlap with other clinical conditions and might present as a challenge, especially in the early phases. Despite the advances and widespread use of imaging modalities, still negative laparotomies are performed with the initial diagnosis of acute appendicitis. Several scoring systems are developed by using various clinical and laboratory parameters in order to improve the diagnostic accuracy and prevent unnecessary laparotomies.

Description:

In the recent guideline of World Society of Emergency Surgeons (WSES) recommendations regarding the clinical scoring systems for acute appendicitis are remarkable. It is stated that clinical scoring systems, on their own, can be used to exclude acute appendicitis and decrease negative laparotomy rates. Currently Appendicitis Inflammatory Response Score (AIR) and Adult Appendicitis Score (AAS) are the best clinically performing scoring systems. As a result, based on strong evidence the use of these two systems are recommended. Both scoring systems are developed on the basis of clinical findings and laboratory parameters. The aim of this study is to validate both systems as well as to compare the efficiency of both systems on excluding negative laparotomies and on the determination of severity of acute appendicitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Presenting to ER with right lower quadrant pain
• Patients between 18-65 years old.

Exclusion Criteria:

• Patients receiving immun-suppressive therapy
• Patients with diagnosed malignancy
• Presence of mental retardation
• Patients with previous right hemicolectomy
• Patients with previous appendectomy
• Pregnant women

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Appendicitis With Rupture
• Acute Disease
• Appendicitis
• Rupture

Intervention

Diagnostic Test:
• Appendicitis Inflammatory Response
A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters
• Adult Appendicitis Score
A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters

Locations

Country	Name	City	State
Turkey	Nigde Ömer Halisdemir University Training and Research Hospital	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Andersson M, Andersson RE. The appendicitis inflammatory response score: a tool for the diagnosis of acute appendicitis that outperforms the Alvarado score. World J Surg. 2008 Aug;32(8):1843-9. doi: 10.1007/s00268-008-9649-y. Erratum in: World J Surg. 2012 Sep;36(9):2269-70. — View Citation

Di Saverio S, Podda M, De Simone B, Ceresoli M, Augustin G, Gori A, Boermeester M, Sartelli M, Coccolini F, Tarasconi A, De' Angelis N, Weber DG, Tolonen M, Birindelli A, Biffl W, Moore EE, Kelly M, Soreide K, Kashuk J, Ten Broek R, Gomes CA, Sugrue M, Davies RJ, Damaskos D, Leppäniemi A, Kirkpatrick A, Peitzman AB, Fraga GP, Maier RV, Coimbra R, Chiarugi M, Sganga G, Pisanu A, De' Angelis GL, Tan E, Van Goor H, Pata F, Di Carlo I, Chiara O, Litvin A, Campanile FC, Sakakushev B, Tomadze G, Demetrashvili Z, Latifi R, Abu-Zidan F, Romeo O, Segovia-Lohse H, Baiocchi G, Costa D, Rizoli S, Balogh ZJ, Bendinelli C, Scalea T, Ivatury R, Velmahos G, Andersson R, Kluger Y, Ansaloni L, Catena F. Diagnosis and treatment of acute appendicitis: 2020 update of the WSES Jerusalem guidelines. World J Emerg Surg. 2020 Apr 15;15(1):27. doi: 10.1186/s13017-020-00306-3. Review. — View Citation

Huckins DS, Copeland K. Diagnostic accuracy of combined WBC, ANC and CRP in adult emergency department patients suspected of acute appendicitis. Am J Emerg Med. 2020 Apr 29. pii: S0735-6757(20)30316-8. doi: 10.1016/j.ajem.2020.04.086. [Epub ahead of print] — View Citation

Ohle R, O'Reilly F, O'Brien KK, Fahey T, Dimitrov BD. The Alvarado score for predicting acute appendicitis: a systematic review. BMC Med. 2011 Dec 28;9:139. doi: 10.1186/1741-7015-9-139. Review. — View Citation

Sammalkorpi HE, Mentula P, Leppäniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclude acute appendicitis	The ability of the scoring systems in detecting patients without acute appendicitis presenting with right lower quadrant pain to emergency service	6 months
Primary	Predicting the severity of acute appendicitis	The ability of scoring systems in predicting the rate of perforation in patients with acute appendicitis	6 months