Right Iliac Fossa Treatment-Turkey Audit

Abdominal Pain Clinical Trial

— RIFT-Turkey  

Official title:

Right Iliac Fossa Treatment-Turkey Audit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614649
• Other study ID #: RIFT-TR
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Abdominal Pain
• Appendicitis
• Appendicitis Acute

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