Acute AppendicitisNCT06956638
Bilirubin Levels to Diagnose Appendicitis and Predict Appendiceal Perforation
An observational study of Acute Appendicitis and Appendicitis Perforated, run by Nepalese Army Institute of Health Sciences at 1 site in Nepal.
Trial summary
The goal of this study is to learn if serum bilirubin levels can aid in the diagnosis of acute appendicitis and predict appendiceal perforation Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Acute Appendicitis, Appendicitis Perforated
- What is being tested?
- Non-interventional
- How many people
- 98 participants
- Where
- 1 siteNepal
- Study dates
- 16 Jul 2022to 12 Mar 2025
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting with acute appendicitis at Shree Birendra Hospital, Chhauni, Kathmandu
Who may be able to join
- Patients of age group above 5 years with acute appendicitis undergoing appendectomy with written informed consent.
Who cannot join
- Patients with appendicular lump.
- Patients with acute and chronic liver diseases like acute hepatitis, hemolytic disease, Gilbert's syndrome, Dubin-Johnson syndrome, alcoholic liver disease.
- Acquired or Congenital Biliary Disease.
- History of Hepatotoxic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Appendiceal Perforation and the Role of Total Bilirubin at Presentation: A Single Center Prospective Cross-sectional Study in Nepal
The goal of this study is to learn if serum bilirubin levels can aid in the diagnosis of acute appendicitis and predict appendiceal perforation
Read the detailed description
The study aims to assess hyperbilirubinemia: serum direct, indirect and total bilirubin to enhance the diagnostic accuracy of acute appendicitis. Also it aims to analyze different patient variables such as age, gender, duration of symptoms, leukocyte and neutrophil count, Alvarado score, presence of fever, nausea \& vomiting, peritonitis alongside serum total bilirubin level in patients with appendicitis and assess which variables can be taken as independent factors to predict appendiceal perforation.
- Conditions
- Acute Appendicitis, Appendicitis Perforated
- Being tested
- Non-interventional
- Keywords
- Single-center, prospective, cross-sectional
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Patients of age group above 5 years with acute appendicitis undergoing appendectomy | Patients of age group above 5 years with acute appendicitis undergoing appendectomy, without acute or chronic liver diseases, acquired or congenital bilirary diseases, history of use of hepatotoxic drugs or diagnosis of appendicular lump Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perforated appendix
Perforated appendicitis was confirmed intraoperatively by the surgeon and at histological analysis of the specimen by the rupture of appendiceal wall to the serosa. Those with gangrenous walls were also taken as perforated.
Measured: Presentation to hospital till perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start16 Jul 2022
- Primary completion15 Jun 2023
- Study completion12 Mar 2025
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 Acute 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
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepalese Army Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhairav Kumar Hamal, MS, Fellow - Urosurgery, Study chair, Nepalese Army Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956638
- Sponsor's protocol ID
- IRB604
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Sirikurnpiboon S, Amornpornchareon S. Factors Associated with Perforated Appendicitis in Elderly Patients in a Tertiary Care Hospital. Surg Res Pract. 2015;2015:847681. doi: 10.1155/2015/847681. Epub 2015 Aug 24.
PubMed 26380377Potey K, Kandi A, Jadhav S, Gowda V. Study of outcomes of perforated appendicitis in adults: a prospective cohort study. Ann Med Surg (Lond). 2023 Mar 16;85(4):694-700. doi: 10.1097/MS9.0000000000000277. eCollection 2023 Apr.
PubMed 37113955Chaudhary P, Kumar A, Saxena N, Biswal UC. Hyperbilirubinemia as a predictor of gangrenous/perforated appendicitis: a prospective study. Ann Gastroenterol. 2013;26(4):325-331.
PubMed 24714371Sand M, Bechara FG, Holland-Letz T, Sand D, Mehnert G, Mann B. Diagnostic value of hyperbilirubinemia as a predictive factor for appendiceal perforation in acute appendicitis. Am J Surg. 2009 Aug;198(2):193-8. doi: 10.1016/j.amjsurg.2008.08.026. Epub 2009 Mar 23.
PubMed 19306980
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Appendiceal Perforation and the Role of Total Bilirubin at Presentation: A Single Center Prospective Cross-sectional Study in Nepal
- ClinicalTrials.gov ID
- NCT06956638
- Acronym / sponsor ID
- IRB604
- Conditions
- Acute Appendicitis, Appendicitis Perforated
- Keywords
- Single-center, prospective, cross-sectional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Nepalese Army Institute of Health SciencesUniversity, hospital or other
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 4 May 2025 (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.
The goal of this study is to learn if serum bilirubin levels can aid in the diagnosis of acute appendicitis and predict appendiceal perforation
Detailed description
The study aims to assess hyperbilirubinemia: serum direct, indirect and total bilirubin to enhance the diagnostic accuracy of acute appendicitis. Also it aims to analyze different patient variables such as age, gender, duration of symptoms, leukocyte and neutrophil count, Alvarado score, presence of fever, nausea \& vomiting, peritonitis alongside serum total bilirubin level in patients with appendicitis and assess which variables can be taken as independent factors to predict appendiceal perforation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of age group above 5 years with acute appendicitis undergoing appendectomy | – | Other: Non-interventionalPatients of age group above 5 years with acute appendicitis undergoing appendectomy, without acute or chronic liver diseases, acquired or congenital bilirary diseases, history of use of hepatotoxic drugs or diagnosis of appendicular lump |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting with acute appendicitis at Shree Birendra Hospital, Chhauni, Kathmandu
Key inclusion criteria (1 listed)
- Patients of age group above 5 years with acute appendicitis undergoing appendectomy with written informed consent.
Key exclusion criteria (4 listed)
- Patients with appendicular lump.
- Patients with acute and chronic liver diseases like acute hepatitis, hemolytic disease, Gilbert's syndrome, Dubin-Johnson syndrome, alcoholic liver disease.
- Acquired or Congenital Biliary Disease.
- History of Hepatotoxic drugs.
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 |
|---|---|---|
| Non-interventionalNon-interventional study | Other | Patients of age group above 5 years with acute appendicitis undergoing appendectomy |
Primary outcome
Perforated appendix
Time frame: Presentation to hospital till perioperative period
Perforated appendicitis was confirmed intraoperatively by the surgeon and at histological analysis of the specimen by the rupture of appendiceal wall to the serosa. Those with gangrenous walls were also taken as perforated.
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 7 May 2025.
- Results publication: PubMed 26380377Sirikurnpiboon S, Amornpornchareon S. Factors Associated with Perforated Appendicitis in Elderly Patients in a Tertiary Care Hospital. Surg Res Pract. 2015;2015:847681. doi: 10.1155/2015/847681. Epub 2015 Aug 24.
- Results publication: PubMed 37113955Potey K, Kandi A, Jadhav S, Gowda V. Study of outcomes of perforated appendicitis in adults: a prospective cohort study. Ann Med Surg (Lond). 2023 Mar 16;85(4):694-700. doi: 10.1097/MS9.0000000000000277. eCollection 2023 Apr.
- Results publication: PubMed 24714371Chaudhary P, Kumar A, Saxena N, Biswal UC. Hyperbilirubinemia as a predictor of gangrenous/perforated appendicitis: a prospective study. Ann Gastroenterol. 2013;26(4):325-331.
- Results publication: PubMed 19306980Sand M, Bechara FG, Holland-Letz T, Sand D, Mehnert G, Mann B. Diagnostic value of hyperbilirubinemia as a predictive factor for appendiceal perforation in acute appendicitis. Am J Surg. 2009 Aug;198(2):193-8. doi: 10.1016/j.amjsurg.2008.08.026. Epub 2009 Mar 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Bhairav Kumar Hamal, MS, Fellow - Urosurgery study chair
Nepalese Army Institute of Health Sciences
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 Acute Appendicitis and Appendicitis Perforated, run by Nepalese Army Institute of Health Sciences at 1 site in Nepal.
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 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 7 May 2025. 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 Nepal. 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?
Perforated appendix (time frame: Presentation to hospital till perioperative period). 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 NCT06956638, 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 7 May 2025.