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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04614649
Other study ID # RIFT-TR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2020
Est. completion date March 1, 2021

Study information

Verified date February 2024
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background: Acute appendicitis stands out as a frequently encountered surgical emergency. Despite decades of experience and research, the diagnosis remains a formidable challenge, particularly in young females experiencing acute abdominal pain, where the assessment requires consideration of a broader spectrum of potential causes. An overarching concern lies in the risk of over-treatment, leading to an escalation in unnecessary surgeries, known as the negative appendectomy rate (NAR). This elevated NAR is associated with postoperative complications, prolonged hospital stays, and avoidable healthcare expenditures. Despite international guidelines recommending the routine use of risk prediction models for patients with acute abdominal pain, reported NAR values have reached as high as 28.2% in females and 12.1% in males. Aim: The primary study aim is to identify optimal risk prediction models for acute RIF pain in Turkey. The secondary aims are to audit the normal appendicectomy rate, assess whether these scores have similar efficacy in immigrants, and demonstrate nationwide clinical trends to discuss possible improvements.


Recruitment information / eligibility

Status Completed
Enrollment 3358
Est. completion date March 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All consecutive patients referred to general surgeons with right iliac fossa pain or suspected appendicitis. - All patients who undergo an appendicectomy during the study period. Exclusion Criteria: - Previous appendicectomy, right hemicolectomy, or total colectomy. - Previous abdominal surgery in the last 90 days. - Pregnancy. - Patients confirmed with COVID-19.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best classification performance among 4 appendicitis scoring systems (for Turkish population) Data is used to calculate the four most commonly used adult risk prediction models: Alvarado, the Appendicitis Inflammatory Response (AIR), Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA), and Adult Appendicitis Score (AAS). Then, the performance of each scoring system will be compared with one another to find the best scoring system among them. During admission
Secondary Normal Appendicectomy Rate (NAR) The NAR value is calculated as the percentage of patients with normal appendix histology who had undergone appendectomy. Patients with appendix pathology other than appendicitis (such as appendix tumor) were included in the denominator but not the numerator. All patients are followed up for 60 days, and data being utilized for NAR calculation is collected within that timeframe.
Secondary Best classification performance among 4 appendicitis scoring systems (for immigrant population) Data is used to calculate the four most commonly used adult risk prediction models: Alvarado, the Appendicitis Inflammatory Response (AIR), Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA), and Adult Appendicitis Score (AAS). Then, the performance of each scoring system will be compared with one another to find the best scoring system among them. During admission
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