Acute Appendicitis in ElderlyNCT04033198
Clinicopathological Aspects of Acute Appendicitis in Patients Above Age of Thirty at Sulaimani Emergency Hospital
An observational study of Acute Appendicitis in Elderly, run by University of Sulaimani.
Trial summary
Aims of this study are : Estimate the incidence of A.A. in patients above age of 30 y in 4 age groups . Correlate between different clinical aspects and histopathological results. Determine rate of negative appendectomy in those patients. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis in Elderly
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Aug 2019
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study includes 70 patients with age above than thirty years old. The patients are divided into 4 age groups :group 1 (30-39 y) , group 2(40-49), group 3(50-59) and group4 (patients older than 60 y) .They were admitted to our emergency hospital with features of acute appendicitis. A detailed history was taken and clinical examination of the patient was carried out at the time of admission .Data was collected regarding investigations (CBC , GUE , US). Appendectomy done for the 70 patient,their operative findings along with any complications as well as histopathological findings were recorded
Who may be able to join
- patients above age of thirty appendectomy done for them
Who cannot join
- patients less than thirty years conservative mangement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Senior House Officer of Trauma and Emergency Surgery
Aims of this study are :
- Estimate the incidence of A.A. in patients above age of 30 y in 4 age groups .
- Correlate between different clinical aspects and histopathological results.
- Determine rate of negative appendectomy in those patients.
Read the detailed description
Acute appendicitisis the clinical condition which refer to inflammation of the vermiform appendix1. It is the most common abdominal emergency2,3,4 .it accounts for more than 40,000 hospital admissions in England every year 5 . Approximately 8% of the population in Western countries would have appendicitis during their life 6 .In the United States, the estimated incidenc of acute appendicitis is 11 cases per 10,000 population 5 . However, in South Africa, the incidencewas estimated to be less than 9 per 100,000 6 .Appendectomy is considered the most common emergency surgical procedure worldwide6,8 ,9. The cause of acute appendicitis is unknown but it is multifactorial; luminal obstruction , dietary and familial factors have been suggested 5 . Fecoliths are the most common cause of obstruction. It was demonstrated that the mean duration of abdominal pain in patients with gangrenous appendix is 46.2 hours and 70.9 hs for perforated 7 .
The peak incidence of acute appendicitis is at the age of 10 to 30 years 6,10. There are special features for appendicitis according to age 1. A.A is primarily a disease of the younger population, with only 5-10% of cases occurring in elderly people, but the incidence of acute appendicitis in elderly began to increase with the increase in life expectancy14. Older patients with acute abdominal pain are high-risk patients, unlike their younger counterparts15 . Morbidity and mortality rates are greater in elderly due to atypical presentations and delay in diagnosis leading to increase rate of perforation and intra-abdominal infection.. They need to be clinically evaluated by experienced surgeons within a narrow time margin14,15.
- Conditions
- Acute Appendicitis in Elderly
- Being tested
- Appendectomy
- Keywords
- Clinico-pathology , acute appendicitis , elderly , aging , histopathology
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
patients diagnosed as acute appendicitis , appendectomy done
| Study group | Role | What they receive |
|---|---|---|
| fourth decade | appendectomy done , appendix send for histopathological examination Receives: Procedure: Appendectomy | |
| fifth decade | appendectomy done , appendix send for histopathological examination Receives: Procedure: Appendectomy | |
| sixth decade | appendectomy done , appendix send for histopathological examination Receives: Procedure: Appendectomy | |
| older than 60 years | appendectomy done , appendix send for histopathological examination Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinico -pathological aspects of acute appendicitis in patients above age of thirty in Sulaimani Emergency hospital
perform appendectomy for all the patients who diagnosed as acute appendicitis
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Appendicitis in ElderlyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sabawi, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033198
- Sponsor's protocol ID
- AA8
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senior House Officer of Trauma and Emergency Surgery
- ClinicalTrials.gov ID
- NCT04033198
- Acronym / sponsor ID
- AA8
- Conditions
- Acute Appendicitis in Elderly
- Keywords
- Clinico-pathology , acute appendicitis , elderly , aging , histopathology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 25 Jul 2019 (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.
Aims of this study are :
- Estimate the incidence of A.A. in patients above age of 30 y in 4 age groups .
- Correlate between different clinical aspects and histopathological results.
- Determine rate of negative appendectomy in those patients.
Detailed description
Acute appendicitisis the clinical condition which refer to inflammation of the vermiform appendix1. It is the most common abdominal emergency2,3,4 .it accounts for more than 40,000 hospital admissions in England every year 5 . Approximately 8% of the population in Western countries would have appendicitis during their life 6 .In the United States, the estimated incidenc of acute appendicitis is 11 cases per 10,000 population 5 . However, in South Africa, the incidencewas estimated to be less than 9 per 100,000 6 .Appendectomy is considered the most common emergency surgical procedure worldwide6,8 ,9. The cause of acute appendicitis is unknown but it is multifactorial; luminal obstruction , dietary and familial factors have been suggested 5 . Fecoliths are the most common cause of obstruction. It was demonstrated that the mean duration of abdominal pain in patients with gangrenous appendix is 46.2 hours and 70.9 hs for perforated 7 .
The peak incidence of acute appendicitis is at the age of 10 to 30 years 6,10. There are special features for appendicitis according to age 1. A.A is primarily a disease of the younger population, with only 5-10% of cases occurring in elderly people, but the incidence of acute appendicitis in elderly began to increase with the increase in life expectancy14. Older patients with acute abdominal pain are high-risk patients, unlike their younger counterparts15 . Morbidity and mortality rates are greater in elderly due to atypical presentations and delay in diagnosis leading to increase rate of perforation and intra-abdominal infection.. They need to be clinically evaluated by experienced surgeons within a narrow time margin14,15.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fourth decade | – | Procedure: Appendectomyappendectomy done , appendix send for histopathological examination |
| fifth decade | – | Procedure: Appendectomyappendectomy done , appendix send for histopathological examination |
| sixth decade | – | Procedure: Appendectomyappendectomy done , appendix send for histopathological examination |
| older than 60 years | – | Procedure: Appendectomyappendectomy done , appendix send for histopathological examination |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes 70 patients with age above than thirty years old. The patients are divided into 4 age groups :group 1 (30-39 y) , group 2(40-49), group 3(50-59) and group4 (patients older than 60 y) .They were admitted to our emergency hospital with features of acute appendicitis. A detailed history was taken and clinical examination of the patient was carried out at the time of admission .Data was collected regarding investigations (CBC , GUE , US). Appendectomy done for the 70 patient,their operative findings along with any complications as well as histopathological findings were recorded
Key inclusion criteria (1 listed)
- patients above age of thirty appendectomy done for them
Key exclusion criteria (1 listed)
- patients less than thirty years conservative mangement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appendectomypatients diagnosed as acute appendicitis , appendectomy done | Procedure or surgery | fifth decade, fourth decade, older than 60 years, sixth decade |
Primary outcome
Clinico -pathological aspects of acute appendicitis in patients above age of thirty in Sulaimani Emergency hospital
Time frame: 2 month
perform appendectomy for all the patients who diagnosed as acute appendicitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis in Elderly, run by University of Sulaimani.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Sabawi, SHO (07705297470, dr.maha.iraqi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinico -pathological aspects of acute appendicitis in patients above age of thirty in Sulaimani Emergency hospital (time frame: 2 month). 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 25 Jul 2019.