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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis; Acute Appendicitis With Rupture
• Intervention / Treatment: Diagnostic test: Appendicitis Inflammatory Response; Diagnostic test: Adult Appendicitis Score

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Turkey
  • Niğde, Turkey, 51100
    • Niğde Ömer Halisdemir University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients between 18-65 years old, presenting to ER with right lower quadrant pain.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right Low Quadrant Pain; AIR and AAS scores will be calculated for the patients with right low quadrant pain in emergency service.	Diagnostic test: Appendicitis Inflammatory Response; A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters; Diagnostic test: Adult Appendicitis Score; A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Predicting the severity of acute appendicitis	The ability of scoring systems in predicting the rate of perforation in patients with acute appendicitis	6 months

Collaborators and Investigators

• Sponsor: Nigde Omer Halisdemir University

Publications and helpful links

General Publications

• 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.
• 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. 2021 Jun;44:401-406. doi: 10.1016/j.ajem.2020.04.086. Epub 2020 Apr 29.
• 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, Leppaniemi 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.
• 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.
• Sammalkorpi HE, Mentula P, Leppaniemi 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Wounds and Injuries; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Rupture; Acute Disease; Appendicitis
• Other Study ID Numbers: 2021/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No