AppendicitisNCT04271826
Grey Zone Appendicitis: Role of Blood Test Biomarkers to Detect Early Appendicitis and to Decrease the Incidence of Negative Appendectomy
A study testing laparoscopic appendectomy in people with Appendicitis, run by Zagazig University at 1 site in Egypt.
Trial summary
Introduction: many investigations emerged in the last decades and contribute towards a diagnosis of unsure appendicitis; they are valuable to the emergency general surgeon. Aim: This study aims to assess the role of laboratory markers (bilirubin and phospholipase A2) individually or combined with Computed Tomography… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Aug 2019
- Phase
- Interventional
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: more than 14years of both sexes.
- Non pregnant female.
- Patients taking analgesics. .Patients who diagnosed to have grey zone diagnosis of acute appendicitis (Alvarado score 5-6).
Who cannot join
- Alvarado score >6 or < 5.
- Cases of sure acute appendicitis.
- Documented Liver disease, biliary disease (congenital or acquired), hemolytic diseases and history of alcoholism.
- 4) Cases revealed other pathology than appendicitis by CT and laparoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Grey Zone Appendicitis (Intermediate Risk Alvarado Score 5-6): Role of Blood Test Biomarkers to Detect Early Appendicitis and to Decrease the Incidence of Negative Appendectomy: Cost and Effectiveness: Randomized Controlled Trial
Introduction: many investigations emerged in the last decades and contribute towards a diagnosis of unsure appendicitis; they are valuable to the emergency general surgeon.
Aim: This study aims to assess the role of laboratory markers (bilirubin and phospholipase A2) individually or combined with Computed Tomography (CT) for the diagnosis of grey zone appendicitis (Alvarado score 5-6).
Methods: This prospective study included all 310 patients admitted with right iliac fossa (RIF) pain who had Alvarado score 5-6 (intermediate risk of appendicitis). All underwent full laboratory investigations including serum total bilirubin and phospholipase A2. All are underwent CT scan and classified into group A with normal CT but with persistent right iliac fossa pain and group B with proved acute appendicitis by CT. All cases underwent a laparoscopic or open appendectomy. Other causes of hyperbilirubine¬mia are excluded among the patients.
Read the detailed description
INTRODUCTION Acute appendicitis is a very common surgical emergency worldwide, with a lifetime risk reported to be 7-8%..Accordingly, appendectomy is the most frequently performed operation worldwide.
Many surgical centers attempt to reduce surgical procedures performed during the night, and delaying appendectomy for 12-24 h does not seem to increase complications
Despite thorough research, the diagnosis of acute appendicitis is still difficult and remains the most common problem in clinical surgery.
In addition to clinical examination of the patients with appendicitis, ultrasonography and multidetector computed tomography (MDCT) have become the most useful tools with a respective sensitivity and specificity of 98.5% and 98.0% in expert centers Routine use of MDCT not only increases exposure to radiation but also very expensive and time-consuming. Thus evolving methods to diagnose early acute appendicitis without radiological examinations are of interest.
Observing serum bilirubin and phospholipase A2 level came into consideration as it seems to elevate in early appendicitis, its determination is fast and can be performed with other commonly performed blood tests.
Bacteria invade the appendix and release tumour necrosis factor-alpha, Interleukien 6, and cytokines. These substances reach the liver through superior mesenteric vein and cause dysfunction of liver either by direct effect or indirectly through altering the hepatic blood flow. So it is important to evaluate the total bilirubin level in the diagnosis of clinically suspected cases of appendicitis (6) THE AIM OF THE WORK
This study aims to evaluate the role of bilirubin and phospholipase A2 in:
- Cases of grey zone unsure appendicitis (intermediate risk Alvarado score 5-6).
- As a complementary to CT.
- Detect early cases of appendicitis.
- Decrease the incidence of negative appendicitis.
- Decrease complications of missed cases of appendicitis.
- Reduce the overnight appendectomy rate with its complications. Patients and methods Cases with normal CT but with persistent right iliac fossa tenderness and failed to improve under conservative treatment for 48 hrs With antibiotic therapy (Group A) underwent laparoscopic appendectomy. Patients proved to be appendicitis by CT underwent laparoscopic exploration (Group B). All the appendices removed were sent for histological examination and the operated cases divided into positive appendicitis (macroscopic or microscopic) and negative appendicitis.
Group A , patients with normal CT but with persistent right iliac fossa pain. Group B , patients with proved acute appendicitis in CT.
- Conditions
- Appendicitis
- Being tested
- laparoscopic appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
cases with normal CT underwent laparoscopic appendectomy
| Study group | Role | What they receive |
|---|---|---|
| cases with normal CT | Experimental | evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis Receives: Procedure: laparoscopic appendectomy |
| cases with proven appendicitis on CT | Experimental | evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum bilirubin level
role of blood biomarker in detecting acute appendicitis
Measured: 1 year
phospholipase A2 level
role of blood biomarker in detecting acute appendicitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
- Investigators
- tamer A. alnaimy, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271826
- Sponsor's protocol ID
- zagu
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grey Zone Appendicitis (Intermediate Risk Alvarado Score 5-6): Role of Blood Test Biomarkers to Detect Early Appendicitis and to Decrease the Incidence of Negative Appendectomy: Cost and Effectiveness: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04271826
- Acronym / sponsor ID
- zagu
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 17 Feb 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.
Introduction: many investigations emerged in the last decades and contribute towards a diagnosis of unsure appendicitis; they are valuable to the emergency general surgeon.
Aim: This study aims to assess the role of laboratory markers (bilirubin and phospholipase A2) individually or combined with Computed Tomography (CT) for the diagnosis of grey zone appendicitis (Alvarado score 5-6).
Methods: This prospective study included all 310 patients admitted with right iliac fossa (RIF) pain who had Alvarado score 5-6 (intermediate risk of appendicitis). All underwent full laboratory investigations including serum total bilirubin and phospholipase A2. All are underwent CT scan and classified into group A with normal CT but with persistent right iliac fossa pain and group B with proved acute appendicitis by CT. All cases underwent a laparoscopic or open appendectomy. Other causes of hyperbilirubine¬mia are excluded among the patients.
Detailed description
INTRODUCTION Acute appendicitis is a very common surgical emergency worldwide, with a lifetime risk reported to be 7-8%..Accordingly, appendectomy is the most frequently performed operation worldwide.
Many surgical centers attempt to reduce surgical procedures performed during the night, and delaying appendectomy for 12-24 h does not seem to increase complications
Despite thorough research, the diagnosis of acute appendicitis is still difficult and remains the most common problem in clinical surgery.
In addition to clinical examination of the patients with appendicitis, ultrasonography and multidetector computed tomography (MDCT) have become the most useful tools with a respective sensitivity and specificity of 98.5% and 98.0% in expert centers Routine use of MDCT not only increases exposure to radiation but also very expensive and time-consuming. Thus evolving methods to diagnose early acute appendicitis without radiological examinations are of interest.
Observing serum bilirubin and phospholipase A2 level came into consideration as it seems to elevate in early appendicitis, its determination is fast and can be performed with other commonly performed blood tests.
Bacteria invade the appendix and release tumour necrosis factor-alpha, Interleukien 6, and cytokines. These substances reach the liver through superior mesenteric vein and cause dysfunction of liver either by direct effect or indirectly through altering the hepatic blood flow. So it is important to evaluate the total bilirubin level in the diagnosis of clinically suspected cases of appendicitis (6) THE AIM OF THE WORK
This study aims to evaluate the role of bilirubin and phospholipase A2 in:
- Cases of grey zone unsure appendicitis (intermediate risk Alvarado score 5-6).
- As a complementary to CT.
- Detect early cases of appendicitis.
- Decrease the incidence of negative appendicitis.
- Decrease complications of missed cases of appendicitis.
- Reduce the overnight appendectomy rate with its complications. Patients and methods Cases with normal CT but with persistent right iliac fossa tenderness and failed to improve under conservative treatment for 48 hrs With antibiotic therapy (Group A) underwent laparoscopic appendectomy. Patients proved to be appendicitis by CT underwent laparoscopic exploration (Group B). All the appendices removed were sent for histological examination and the operated cases divided into positive appendicitis (macroscopic or microscopic) and negative appendicitis.
Group A , patients with normal CT but with persistent right iliac fossa pain. Group B , patients with proved acute appendicitis in CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases with normal CT | Experimental | Procedure: laparoscopic appendectomyevaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis |
| cases with proven appendicitis on CT | Experimental | Procedure: laparoscopic appendectomyevaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: more than 14years of both sexes.
- Non pregnant female.
- Patients taking analgesics. .Patients who diagnosed to have grey zone diagnosis of acute appendicitis (Alvarado score 5-6).
Key exclusion criteria (4 listed)
- Alvarado score >6 or < 5.
- Cases of sure acute appendicitis.
- Documented Liver disease, biliary disease (congenital or acquired), hemolytic diseases and history of alcoholism.
- 4) Cases revealed other pathology than appendicitis by CT and laparoscopy.
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 |
|---|---|---|
| laparoscopic appendectomycases with normal CT underwent laparoscopic appendectomy | Procedure or surgery | cases with normal CT, cases with proven appendicitis on CT |
Primary outcome
serum bilirubin level
Time frame: 1 year
role of blood biomarker in detecting acute appendicitis
phospholipase A2 level
Time frame: 1 year
role of blood biomarker in detecting acute appendicitis
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 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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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.
tamer A. alnaimy, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic appendectomy in people with Appendicitis, run by Zagazig University at 1 site in Egypt.
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 3 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 17 Feb 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 Egypt. 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?
serum bilirubin level (time frame: 1 year). 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 17 Feb 2020.