AppendicitisNCT06462846
Evaluation of Clinical Characteristics and Pathological Findings in Patients With Suspected Appendicitis
An observational study of Appendicitis, run by Golestan University of Medical sciences at 1 site in Iran.
Trial summary
As we know, one of the most common reasons for people to visit health centers and hospitals (15%) is abdominal pain, and appendicitis is at the top of their diagnosis in the 2-4th decade of age, which in most cases For treatment, considering the patient's condition and the need for surgery, appendectomy is the first… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis
- How many people
- 291 participants
- Where
- 1 siteIran
- Study dates
- 19 Apr 2022to 30 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patents operated with the diagnosis of appendicitis in 5th azar medical center, in 2022
Who may be able to join
- diagnosis of appendicitis
- appendectomy
Who cannot join
- Lack of required information in medical documents
Trial locations and contacts
1 site in 1 country.
Iran1 site
Golestan University of Medical Sciences, faculty of medicine
Gorgan, Golestan Province, 4918936316
About this study
Official title: Evaluation of Demographic and Clinical Characteristics and Intraoperative and Pathological Findings in Patients With Suspected Appendicitis Who Underwent Appendectomy in 5 Azar Hospital in 2022
As we know, one of the most common reasons for people to visit health centers and hospitals (15%) is abdominal pain, and appendicitis is at the top of their diagnosis in the 2-4th decade of age, which in most cases For treatment, considering the patient's condition and the need for surgery, appendectomy is the first method. One of the things that helps us a lot in this area is the epidemiology and incidence of this disease in the target society, which sometimes varies in different regions. One of the things that can be checked in this disease is the age and gender of the person and its incidence in different age ranges.
Read the detailed description
appendicitis is one of the most important reasons for people to go to the hospital, and 15% of the visits to the hospital are for this reason, and sometimes patients end up undergoing appendectomy. The mortality rate of this disease is 0.2-1% among young people and 8% among people over 65 years old In some people, depending on the sex, age, pregnancy and related diseases and even the weight of the people, the location of the appendix is different and this issue is very important during surgery. Different positions of the appendix, such as retro-scapular, subhepatic, pelvic, etc., create different challenges during surgery, so investigating the possibilities of the location of the appendix is an important issue in the decision-making and preparation of the patient and the surgical team.
Also, laboratory criteria such as wbc, diff, plt, crp can also help in diagnosing this disease. In this project, in addition to the above, the chief complaints and accompanying symptoms of people have also been examined
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Appendectomy, Appendicitis diagnosis
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of imaging in determining the size of the appendix in patients with suspected appendicitis
comparison of the appendix size reported in radiologic studies with pathologic findings
Measured: One year
Secondary outcomes (5)
correlation between CRP levels and pathologic findings in patients with suspected appendicitis
Comparison of CRP levels in the different stages of appendicitis according to pathologic reports
Measured: One year
correlation between WBC measures and pathologic findings in patients with suspected appendicitis
Comparison of WBC measures in the different stages of appendicitis according to pathologic reports
Measured: One year
sex distribution in patients with suspected appendicitis
the prevalence and percentage of each sex group in patients with suspected appendicitis
Measured: one year
Age distribution in patients with suspected appendicitis
the prevalence and percentage of each age group in patients with suspected appendicitis
Measured: one year
prevalence of clinical findings in patients with suspected appendicitis
prevalence and percentage of each clinical finding (fever, anorexia, shifting pain, tenderness, rebound tenderness, rovsing sign, psoas sign) in patients with suspected appendicitis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start19 Apr 2022
- Primary completion20 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ronak jalali, Golestan University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462846
- Sponsor's protocol ID
- 113867
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Park YS, Choi JS. The epidemiology of appendicitis and appendectomy in South Korea: national registry data. J Epidemiol. 2010;20(2):97-105. doi: 10.2188/jea.je20090011. Epub 2009 Dec 19.
PubMed 20023368Golz RA, Flum DR, Sanchez SE, Liu X, Donovan C, Drake FT. Geographic Association Between Incidence of Acute Appendicitis and Socioeconomic Status. JAMA Surg. 2020 Apr 1;155(4):330-338. doi: 10.1001/jamasurg.2019.6030.
PubMed 32129808Tavra A, Quien D, Barcot O. Oncological aspect of incidental appendectomy with regard to histopathological findings: A retrospective cohort study. Eur J Surg Oncol. 2023 Oct;49(10):107013. doi: 10.1016/j.ejso.2023.107013. Epub 2023 Aug 11.
PubMed 37597285Yagmur Y, Sogutcu N, Gumus S. Recent classifications systems for gastroenteropancreatic neuroendocrine tumors A single-center experience. Ann Ital Chir. 2020;91:598-604.
PubMed 32989209Bayhan Z, Yildiz YA, Akdeniz Y, Gonullu E, Altintoprak F, Mantoglu B, Capoglu R, Kahyaoglu Akkaya Z. Appendix Neuroendocrine Tumor: Retrospective Analysis of 4026 Appendectomy Patients in a Single Center. Emerg Med Int. 2020 Sep 3;2020:4030527. doi: 10.1155/2020/4030527. eCollection 2020.
PubMed 32963833Henriksen SR, Rosenberg J, Fonnes S. Other Pathologies Were Rarely Reported after Laparoscopic Surgery for Suspected Appendicitis: A Systematic Review and Meta-Analysis. Dig Surg. 2023;40(3-4):91-99. doi: 10.1159/000531283. Epub 2023 Jul 18.
PubMed 37463567Jukic M, Nizeteo P, Matas J, Pogorelic Z. Trends and Predictors of Pediatric Negative Appendectomy Rates: A Single-Centre Retrospective Study. Children (Basel). 2023 May 15;10(5):887. doi: 10.3390/children10050887.
PubMed 37238435Pineda Villeda RH, Flores Reyes DL, Suazo Rivera JF. Acute Appendicitis: Epidemiological, Clinical, Surgical, and Post-surgical Characteristics in a Honduran General Hospital. Cureus. 2023 Jun 14;15(6):e40428. doi: 10.7759/cureus.40428. eCollection 2023 Jun.
PubMed 37456484
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demographic and Clinical Characteristics and Intraoperative and Pathological Findings in Patients With Suspected Appendicitis Who Underwent Appendectomy in 5 Azar Hospital in 2022
- ClinicalTrials.gov ID
- NCT06462846
- Acronym / sponsor ID
- 113867
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Appendectomy, Appendicitis diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 17 Jun 2024 (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.
As we know, one of the most common reasons for people to visit health centers and hospitals (15%) is abdominal pain, and appendicitis is at the top of their diagnosis in the 2-4th decade of age, which in most cases For treatment, considering the patient's condition and the need for surgery, appendectomy is the first method. One of the things that helps us a lot in this area is the epidemiology and incidence of this disease in the target society, which sometimes varies in different regions. One of the things that can be checked in this disease is the age and gender of the person and its incidence in different age ranges.
Detailed description
appendicitis is one of the most important reasons for people to go to the hospital, and 15% of the visits to the hospital are for this reason, and sometimes patients end up undergoing appendectomy. The mortality rate of this disease is 0.2-1% among young people and 8% among people over 65 years old In some people, depending on the sex, age, pregnancy and related diseases and even the weight of the people, the location of the appendix is different and this issue is very important during surgery. Different positions of the appendix, such as retro-scapular, subhepatic, pelvic, etc., create different challenges during surgery, so investigating the possibilities of the location of the appendix is an important issue in the decision-making and preparation of the patient and the surgical team.
Also, laboratory criteria such as wbc, diff, plt, crp can also help in diagnosing this disease. In this project, in addition to the above, the chief complaints and accompanying symptoms of people have also been examined
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patents operated with the diagnosis of appendicitis in 5th azar medical center, in 2022
Key inclusion criteria (2 listed)
- diagnosis of appendicitis
- appendectomy
Key exclusion criteria (1 listed)
- Lack of required information in medical documents
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
The accuracy of imaging in determining the size of the appendix in patients with suspected appendicitis
Time frame: One year
comparison of the appendix size reported in radiologic studies with pathologic findings
5 secondary outcomes
correlation between CRP levels and pathologic findings in patients with suspected appendicitis
Time frame: One year
correlation between WBC measures and pathologic findings in patients with suspected appendicitis
Time frame: One year
sex distribution in patients with suspected appendicitis
Time frame: one year
Age distribution in patients with suspected appendicitis
Time frame: one year
prevalence of clinical findings in patients with suspected appendicitis
Time frame: one year
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 17 Jun 2024.
- Background: PubMed 20023368Lee JH, Park YS, Choi JS. The epidemiology of appendicitis and appendectomy in South Korea: national registry data. J Epidemiol. 2010;20(2):97-105. doi: 10.2188/jea.je20090011. Epub 2009 Dec 19.
- Background: PubMed 32129808Golz RA, Flum DR, Sanchez SE, Liu X, Donovan C, Drake FT. Geographic Association Between Incidence of Acute Appendicitis and Socioeconomic Status. JAMA Surg. 2020 Apr 1;155(4):330-338. doi: 10.1001/jamasurg.2019.6030.
- Background: PubMed 37597285Tavra A, Quien D, Barcot O. Oncological aspect of incidental appendectomy with regard to histopathological findings: A retrospective cohort study. Eur J Surg Oncol. 2023 Oct;49(10):107013. doi: 10.1016/j.ejso.2023.107013. Epub 2023 Aug 11.
- Background: PubMed 32989209Yagmur Y, Sogutcu N, Gumus S. Recent classifications systems for gastroenteropancreatic neuroendocrine tumors A single-center experience. Ann Ital Chir. 2020;91:598-604.
- Background: PubMed 32963833Bayhan Z, Yildiz YA, Akdeniz Y, Gonullu E, Altintoprak F, Mantoglu B, Capoglu R, Kahyaoglu Akkaya Z. Appendix Neuroendocrine Tumor: Retrospective Analysis of 4026 Appendectomy Patients in a Single Center. Emerg Med Int. 2020 Sep 3;2020:4030527. doi: 10.1155/2020/4030527. eCollection 2020.
- Background: PubMed 37463567Henriksen SR, Rosenberg J, Fonnes S. Other Pathologies Were Rarely Reported after Laparoscopic Surgery for Suspected Appendicitis: A Systematic Review and Meta-Analysis. Dig Surg. 2023;40(3-4):91-99. doi: 10.1159/000531283. Epub 2023 Jul 18.
- Background: PubMed 37238435Jukic M, Nizeteo P, Matas J, Pogorelic Z. Trends and Predictors of Pediatric Negative Appendectomy Rates: A Single-Centre Retrospective Study. Children (Basel). 2023 May 15;10(5):887. doi: 10.3390/children10050887.
- Results publication: PubMed 37456484Pineda Villeda RH, Flores Reyes DL, Suazo Rivera JF. Acute Appendicitis: Epidemiological, Clinical, Surgical, and Post-surgical Characteristics in a Honduran General Hospital. Cureus. 2023 Jun 14;15(6):e40428. doi: 10.7759/cureus.40428. eCollection 2023 Jun.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Appendicitis, run by Golestan University of Medical sciences at 1 site in Iran.
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 1 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 17 Jun 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 Iran. 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?
The accuracy of imaging in determining the size of the appendix in patients with suspected appendicitis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462846, which also lists 8 linked publications.
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 17 Jun 2024.