Acute AppendicitisNCT04730752
Validation and Comparison of the Appendicitis Inflammatory Response Score and Adult Appendicitis Score
An observational study of Acute Appendicitis and Acute Appendicitis With Rupture, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Appendicitis, Acute Appendicitis With Rupture
- What is being tested?
- Appendicitis Inflammatory Response and Adult Appendicitis Score
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 25 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 18-65 years old, presenting to ER with right lower quadrant pain.
Who may be able to join
- Presenting to ER with right lower quadrant pain
- Patients between 18-65 years old.
Who cannot join
- Patients receiving immun-suppressive therapy
- Patients with diagnosed malignancy
- Presence of mental retardation
- Patients with previous right hemicolectomy
- Patients with previous appendectomy
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Training and Research Hospital
Niğde, 51100
About this study
Official title: 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.
Read the 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.
- Being tested
- Appendicitis Inflammatory Response, Adult Appendicitis Score
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appendicitis Inflammatory ResponseDiagnostic test
A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters
Adult Appendicitis ScoreDiagnostic test
A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters
| Study group | Role | What they receive |
|---|---|---|
| Right Low Quadrant Pain | AIR and AAS scores will be calculated for the patients with right low quadrant pain in emergency service. Receives: Diagnostic Test: Appendicitis Inflammatory Response; Diagnostic Test: Adult Appendicitis Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclude acute appendicitis
The ability of the scoring systems in detecting patients without acute appendicitis presenting with right lower quadrant pain to emergency service
Measured: 6 months
Predicting the severity of acute appendicitis
The ability of scoring systems in predicting the rate of perforation in patients with acute appendicitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Mar 2021
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alirıza Erdoğan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730752
- Sponsor's protocol ID
- 2021/07
- Status last verified
- May 2021
- First submitted
- 24 Jan 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22204638Huckins 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.
PubMed 32482481Di 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.
PubMed 32295644Andersson 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.
PubMed 18553045Sammalkorpi 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.
PubMed 24970111
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial on Validation and Comparison of the Diagnostic and Prognostic Value of Appendicitis Inflammatory Response Score and Adult Appendicitis Score
- ClinicalTrials.gov ID
- NCT04730752
- Acronym / sponsor ID
- 2021/07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right Low Quadrant Pain | – | Diagnostic Test: Appendicitis Inflammatory Response, Diagnostic Test: Adult Appendicitis ScoreAIR and AAS scores will be calculated for the patients with right low quadrant pain in emergency service. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18-65 years old, presenting to ER with right lower quadrant pain.
Key inclusion criteria (2 listed)
- Presenting to ER with right lower quadrant pain
- Patients between 18-65 years old.
Key exclusion criteria (6 listed)
- Patients receiving immun-suppressive therapy
- Patients with diagnosed malignancy
- Presence of mental retardation
- Patients with previous right hemicolectomy
- Patients with previous appendectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appendicitis Inflammatory ResponseA scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters | Diagnostic test | Right Low Quadrant Pain |
| Adult Appendicitis ScoreA scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters | Diagnostic test | Right Low Quadrant Pain |
Primary outcome
Exclude acute appendicitis
Time frame: 6 months
The ability of the scoring systems in detecting patients without acute appendicitis presenting with right lower quadrant pain to emergency service
Predicting the severity of acute appendicitis
Time frame: 6 months
The ability of scoring systems in predicting the rate of perforation in patients with acute appendicitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Background: PubMed 22204638Ohle 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.
- Background: PubMed 32482481Huckins 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.
- Background: PubMed 32295644Di 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.
- Background: PubMed 18553045Andersson 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.
- Background: PubMed 24970111Sammalkorpi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis and Acute Appendicitis With Rupture, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclude acute appendicitis (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730752, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.