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Completed

NCT Number: NCT04614649

Right Iliac Fossa Treatment-Turkey Audit

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.

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Key information

Conditions

Abdominal Pain Appendicitis Appendicitis Acute Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, 06560, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Best classification performance among 4 appendicitis scoring systems (for Turkish population)

    Time frame: During admission

    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.

Secondary outcomes

  1. Normal Appendicectomy Rate (NAR)

    Time frame: All patients are followed up for 60 days, and data being utilized for NAR calculation is collected within that timeframe.

    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.

  2. Best classification performance among 4 appendicitis scoring systems (for immigrant population)

    Time frame: During admission

    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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Acronym: RIFT-Turkey

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 4, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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