Abdominal PainRIFT-TurkeyNCT04614649
Right Iliac Fossa Treatment-Turkey Audit
An observational study of Abdominal Pain and Appendicitis, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain, Appendicitis, Appendicitis Acute
- How many people
- 3,358 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2020to 1 Mar 2021
- How long will I take part?
- 60 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to general surgeons with right iliac fossa pain or suspected appendicitis.
Who may be able to join
- 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.
Who cannot join
- Previous appendicectomy, right hemicolectomy, or total colectomy.
- Previous abdominal surgery in the last 90 days.
- Pregnancy.
- Patients confirmed with COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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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.
- Conditions
- Abdominal Pain, Appendicitis, Appendicitis Acute
- Keywords
- appendicitis, appendectomy, right iliac fossa, abdominal pain
- Medical subject headings
- Abdominal Pain, Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During admission
Secondary outcomes (2)
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.
Measured: 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)
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.
Measured: During admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start10 Sep 2020
- Primary completion31 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 3,358 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yalcinkaya, Gazi University
- Investigators
- Sezai Leventoglu, Professor, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614649
- Sponsor's protocol ID
- RIFT-TR
- Acronym
- RIFT-Turkey
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Iliac Fossa Treatment-Turkey Audit
- ClinicalTrials.gov ID
- NCT04614649
- Acronym / sponsor ID
- RIFT-Turkey / RIFT-TR
- Conditions
- Abdominal Pain, Appendicitis, Appendicitis Acute
- Keywords
- appendicitis, appendectomy, right iliac fossa, abdominal pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,358 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Nov 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to general surgeons with right iliac fossa pain or suspected appendicitis.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Previous appendicectomy, right hemicolectomy, or total colectomy.
- Previous abdominal surgery in the last 90 days.
- Pregnancy.
- Patients confirmed with COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
Best classification performance among 4 appendicitis scoring systems (for immigrant population)
Time frame: During admission
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 8 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Sezai Leventoglu, Professor study chair
Gazi University
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 Abdominal Pain and Appendicitis, run by Gazi 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 4 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 8 Feb 2024. 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?
Best classification performance among 4 appendicitis scoring systems (for Turkish population) (time frame: During admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.