NCT04614649

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

October 29, 2020

Last Update Submit

February 5, 2024

Conditions

Keywords

appendicitisappendectomyright iliac fossaabdominal pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Normal Appendicectomy Rate (NAR)

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

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

    During admission

Eligibility Criteria

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

Patients referred to general surgeons with right iliac fossa pain or suspected appendicitis.

You may qualify if:

  • 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.

You may not qualify if:

  • Previous appendicectomy, right hemicolectomy, or total colectomy.
  • Previous abdominal surgery in the last 90 days.
  • Pregnancy.
  • Patients confirmed with COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Abdominal PainAppendicitis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Sezai Leventoglu, Professor

    Gazi University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

September 10, 2020

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations