Parasitic DiseaseNCT04576273
Enterobius Vermicularis Infestation of the Appendix
An observational study of Parasitic Disease, run by Al-Azhar University at 1 site in Saudi Arabia.
Trial summary
This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis. Read more about this study
- Who is it for?
- Ages 4 to 90 years
- Conditions the study is for
- Parasitic Disease
- What is being tested?
- Pathology examination
- How many people
- 1,150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2017to 31 May 2020
- 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 4 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Saudi and non- Saudi patients suffering from acute appendicitis symptoms
Who may be able to join
- All routine examined appendectomy specimens
Who cannot join
- Cases with clinical suspicion of tumor Cases attached to the colectomy specimens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enterobius Vermicularis in Appendectomy Specimens; Clinicopathological Assessment
This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis.
Read the detailed description
All the patients undergoing appendectomy surgical procedure for clinical picture of acute appendicitis in 3-years period at our referral hospital were evaluated to pick up the Enterobius vermicularis infestation of the appendix. These cases were evaluated for clinico-laboratory characterization to define the incidence in our country and the relationship between the E.v and initiation of the the inflammatory process to study the possibility of limitation of surgical intervention in acute abdomen conditions.
- Conditions
- Parasitic Disease
- Being tested
- Pathology examination
- Medical subject headings
- Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathology examinationDiagnostic test
Gross and microscopic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Non-parasitic | Not described Receives: Diagnostic Test: Pathology examination | |
| Parasitic | Not described Receives: Diagnostic Test: Pathology examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between acute inflammation and Enterobius vermicularis infestation
All the studied Enterobius vermicularis cases will be evaluated microscopically to record the count of acute inflammatory cells per millimeter (mm) and per High Power Field (HPF) using the microscope scale measurement. This count will be compared with the inflamed appendectomy specimens without Enterobius infestation to assess the hypothesis of the association between the Enterobius infestation and the acute appendicitis. Also special stain (congo red) will be implicated in some indicated cases to detect eosinophils, eosinophils will be positively staines (orange color stain means positive) if the stain is faint that means negative and the cell is not eosinophil
Measured: 3 years
Incidence of Appendiceal Enterobius vermicularis
An incidence of Enterobius infestation will be assessed by studying all the received specimens during a 3 years-period using formatting a master sheet and processing in Excel program
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Jun 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasitic DiseaseStudies 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
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aabdulkarim Hasan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576273
- Sponsor's protocol ID
- 3003
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enterobius Vermicularis in Appendectomy Specimens; Clinicopathological Assessment
- ClinicalTrials.gov ID
- NCT04576273
- Acronym / sponsor ID
- 3003
- Conditions
- Parasitic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 6 Oct 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.
This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis.
Detailed description
All the patients undergoing appendectomy surgical procedure for clinical picture of acute appendicitis in 3-years period at our referral hospital were evaluated to pick up the Enterobius vermicularis infestation of the appendix. These cases were evaluated for clinico-laboratory characterization to define the incidence in our country and the relationship between the E.v and initiation of the the inflammatory process to study the possibility of limitation of surgical intervention in acute abdomen conditions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-parasitic | – | Diagnostic Test: Pathology examination |
| Parasitic | – | Diagnostic Test: Pathology examination |
Who may qualify
- Ages
- 4 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Saudi and non- Saudi patients suffering from acute appendicitis symptoms
Key inclusion criteria (1 listed)
- All routine examined appendectomy specimens
Key exclusion criteria (1 listed)
- Cases with clinical suspicion of tumor Cases attached to the colectomy specimens
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 |
|---|---|---|
| Pathology examinationGross and microscopic evaluation | Diagnostic test | Non-parasitic, Parasitic |
Primary outcome
Association between acute inflammation and Enterobius vermicularis infestation
Time frame: 3 years
All the studied Enterobius vermicularis cases will be evaluated microscopically to record the count of acute inflammatory cells per millimeter (mm) and per High Power Field (HPF) using the microscope scale measurement. This count will be compared with the inflamed appendectomy specimens without Enterobius infestation to assess the hypothesis of the association between the Enterobius infestation and the acute appendicitis. Also special stain (congo red) will be implicated in some indicated cases to detect eosinophils, eosinophils will be positively staines (orange color stain means positive) if the stain is faint that means negative and the cell is not eosinophil
Incidence of Appendiceal Enterobius vermicularis
Time frame: 3 years
An incidence of Enterobius infestation will be assessed by studying all the received specimens during a 3 years-period using formatting a master sheet and processing in Excel program
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 6 Oct 2020.
Related trials for Parasitic Disease
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
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 Parasitic Disease, run by Al-Azhar University at 1 site in Saudi Arabia.
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: finished, as of the sponsor's last update on 6 Oct 2020. 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 Saudi Arabia. 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?
Association between acute inflammation and Enterobius vermicularis infestation (time frame: 3 years). The study lists 2 primary outcomes in all. 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 6 Oct 2020.