NCT04730752

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

January 24, 2021

Last Update Submit

May 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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 ResponseDiagnostic Test: Adult Appendicitis Score

Interventions

A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters

Right Low Quadrant Pain

A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters

Right Low Quadrant Pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, 51100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 22204638BACKGROUND
  • 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.

    PMID: 32482481BACKGROUND
  • 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.

    PMID: 32295644BACKGROUND
  • 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.

    PMID: 18553045BACKGROUND
  • 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.

    PMID: 24970111BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 29, 2021

Study Start

March 1, 2021

Primary Completion

May 25, 2021

Study Completion

May 25, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations