Complicated AppendicitisNCT06102239
New Diagnostic Markers In Dignosis Of Complicated Appendix
A study testing Bilirubin level sodium level c reactive protein level in people with Complicated Appendicitis, run by Sohag University at 1 site in Egypt.
Trial summary
Most common cause of acute abdomen is acute appendicitis delay dignosis of acute appendicitis lead to complications as perforation this study examined efficacy of hyperbilirubinemia\&hyponatremia as indicator of complicated appendicitis Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Complicated Appendicitis
- What is being tested?
- Bilirubin level sodium level c reactive protein level
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 31 Mar 2024
- 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 10 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all patient admitted for acute appendicitis underwent surgery and post operativly confirmed histopathology of acute appendicitis
Who cannot join
- patient with liver disease Liver transplantation Chronic alcoholism Congental biliary disease Pregnancy Appendicular neoplasm Hemolytic disease Hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
Omar A Syed, Professor contact
About this study
Most common cause of acute abdomen is acute appendicitis delay dignosis of acute appendicitis lead to complications as perforation this study examined efficacy of hyperbilirubinemia\&hyponatremia as indicator of complicated appendicitis
- Conditions
- Complicated Appendicitis
- Being tested
- Bilirubin level sodium level c reactive protein level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilirubin level sodium level c reactive protein levelDiagnostic test
detect level of bilirubin,sodium \&c-reactive protein as indicator of complicated appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of bilirubin in acute appendicitis
Measured: 6 months
Level of sodium in acute appendicitis
Measured: 6 months
Level of c-reactive proteins in acute appendicitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complicated AppendicitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Amin, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102239
- Sponsor's protocol ID
- Soh-Med-23-09-08Ms
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Virmani S, Prabhu PS, Sundeep PT, Kumar V. Role of laboratory markers in predicting severity of acute appendicitis. Afr J Paediatr Surg. 2018 Jan-Mar;15(1):1-4. doi: 10.4103/ajps.AJPS_47_16.
PubMed 30829300Kar S, Behera TK, Jena K, Sahoo AK. Hyperbilirubinemia as a Possible Predictor of Appendiceal Perforation in Acute Appendicitis: A Prospective Study. Cureus. 2022 Feb 2;14(2):e21851. doi: 10.7759/cureus.21851. eCollection 2022 Feb.
PubMed 35282512Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.
PubMed 3963537Kanumba ES, Mabula JB, Rambau P, Chalya PL. Modified Alvarado Scoring System as a diagnostic tool for acute appendicitis at Bugando Medical Centre, Mwanza, Tanzania. BMC Surg. 2011 Feb 17;11:4. doi: 10.1186/1471-2482-11-4.
PubMed 21329493
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Diagnostic Markers In Dignosis Of Complicated Appendix
- ClinicalTrials.gov ID
- NCT06102239
- Acronym / sponsor ID
- Soh-Med-23-09-08Ms
- Conditions
- Complicated Appendicitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
Most common cause of acute abdomen is acute appendicitis delay dignosis of acute appendicitis lead to complications as perforation this study examined efficacy of hyperbilirubinemia\&hyponatremia as indicator of complicated appendicitis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all patient admitted for acute appendicitis underwent surgery and post operativly confirmed histopathology of acute appendicitis
Key exclusion criteria (1 listed)
- patient with liver disease Liver transplantation Chronic alcoholism Congental biliary disease Pregnancy Appendicular neoplasm Hemolytic disease Hepatocellular carcinoma
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 |
|---|---|---|
| Bilirubin level sodium level c reactive protein leveldetect level of bilirubin,sodium \&c-reactive protein as indicator of complicated appendicitis | Diagnostic test | – |
Primary outcome
Level of bilirubin in acute appendicitis
Time frame: 6 months
Level of sodium in acute appendicitis
Time frame: 6 months
Level of c-reactive proteins in acute appendicitis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 30829300Virmani S, Prabhu PS, Sundeep PT, Kumar V. Role of laboratory markers in predicting severity of acute appendicitis. Afr J Paediatr Surg. 2018 Jan-Mar;15(1):1-4. doi: 10.4103/ajps.AJPS_47_16.
- Background: PubMed 35282512Kar S, Behera TK, Jena K, Sahoo AK. Hyperbilirubinemia as a Possible Predictor of Appendiceal Perforation in Acute Appendicitis: A Prospective Study. Cureus. 2022 Feb 2;14(2):e21851. doi: 10.7759/cureus.21851. eCollection 2022 Feb.
- Background: PubMed 3963537Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.
- Background: PubMed 21329493Kanumba ES, Mabula JB, Rambau P, Chalya PL. Modified Alvarado Scoring System as a diagnostic tool for acute appendicitis at Bugando Medical Centre, Mwanza, Tanzania. BMC Surg. 2011 Feb 17;11:4. doi: 10.1186/1471-2482-11-4.
- Individual participant dataSharing planned: Undecided
Related trials for Complicated Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
RecruitingPhase 4
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Laparoscopic Appendectomy, Complicated Appendicitis
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.
Omar A Syed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilirubin level sodium level c reactive protein level in people with Complicated Appendicitis, run by Sohag 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 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 26 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Amin, Residents (01113486740, amr_mohamed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of bilirubin in acute appendicitis (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT06102239, which also lists 4 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 26 Oct 2023.