Acute AppendicitisNCT04689906
Patient Time and In-hospital Delay of Surgery Association With Complicated Appendicitis
An observational study of Acute Appendicitis, run by Rambam Health Care Campus.
Trial summary
This is a retrospective observational study with its main aim of evaluating possible factors associated with complicated appendicitis. Current literature supports time from symptom onset until registration as the main and maybe only determinant of the outcome if patients are operated on within 24 hours. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- surgery
- How many people
- 3,137 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2006to 1 Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated in one medical center during one decade.
Who may be able to join
- male and female patients of all ages who underwent appendectomy of acute appendicitis in a single medical center between December 1, 2006, and December 31, 2016
Who cannot join
- interval appendectomy,
- incidental appendectomy,
- appendectomy after failed antibiotic treatment for either acute appendicitis or peri-appendicular abscess
- patients with a non-inflamed appendix
- those in whom symptom onset before hospitalization was not noted.
About this study
Official title: In-hospital Delay of Surgery Increases the Rate of Complicated Appendicitis in Patients Presenting With Short Duration of Symptoms: a Retrospective Cohort Study
This is a retrospective observational study with its main aim of evaluating possible factors associated with complicated appendicitis. Current literature supports time from symptom onset until registration as the main and maybe only determinant of the outcome if patients are operated on within 24 hours. We wish to evaluate whether this is true in all patients, or there are subgroups in which time from registration to operation is associated with complicated appendicitis.
Read the detailed description
The data to be analyzed is that of patients operated on acutely for suspected appendicitis within 10 years in one medical center. Patients undergoing interval or incidental appendectomies will not be included. The endpoint to be evaluated is complicated appendicitis (gangrenous, abscess, perforated). The independent variables will include mainly sex, age, patient time (time from symptom onset to registration), hospital time (time from registration to operation), and missed diagnosis.
- Conditions
- Acute Appendicitis
- Being tested
- surgery
- Keywords
- Appendicitis, Ruptured Appendicitis, Appendectomy, Timing of Surgery
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
This is a retrospective study that includes patients operated for suspicion of acute appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of complicated appendicitis
complicated appendicitis defined as either gangrenous appendicitis, perforation with abscess, perforation with local peritonitis, perforation with diffuse peritonitis
Measured: finding during surgery/pathology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Dec 2006
- Primary completion31 Dec 2016
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Hillel Yaffe Medical Center
- Responsible party
- Principal investigator, Itamar Ashkenazi MD, Rambam Health Care Campus
- Investigators
- Itamar Ashkenazi, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689906
- Sponsor's protocol ID
- HTVSPTAPP1
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be made available upon reasonable request
Publications
Ashkenazi I, Zeina AR, Olsha O. Early ultrasound in acute appendicitis avoids CT in most patients but delays surgery and increases complicated appendicitis if nondiagnostic - A retrospective study. Am J Surg. 2020 Apr;219(4):683-689. doi: 10.1016/j.amjsurg.2019.05.013. Epub 2019 May 25.
PubMed 31153584Ashkenazi I, Zeina AR, Olsha O. In-hospital delay of surgery increases the rate of complicated appendicitis in patients presenting with short duration of symptoms: a retrospective cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3879-3886. doi: 10.1007/s00068-022-01912-3. Epub 2022 Feb 24.
PubMed 35211772
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Delay of Surgery Increases the Rate of Complicated Appendicitis in Patients Presenting With Short Duration of Symptoms: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04689906
- Acronym / sponsor ID
- HTVSPTAPP1
- Conditions
- Acute Appendicitis
- Keywords
- Appendicitis, Ruptured Appendicitis, Appendectomy, Timing of Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,137 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Hillel Yaffe Medical Center
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 30 Dec 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 is a retrospective observational study with its main aim of evaluating possible factors associated with complicated appendicitis. Current literature supports time from symptom onset until registration as the main and maybe only determinant of the outcome if patients are operated on within 24 hours. We wish to evaluate whether this is true in all patients, or there are subgroups in which time from registration to operation is associated with complicated appendicitis.
Detailed description
The data to be analyzed is that of patients operated on acutely for suspected appendicitis within 10 years in one medical center. Patients undergoing interval or incidental appendectomies will not be included. The endpoint to be evaluated is complicated appendicitis (gangrenous, abscess, perforated). The independent variables will include mainly sex, age, patient time (time from symptom onset to registration), hospital time (time from registration to operation), and missed diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated in one medical center during one decade.
Key inclusion criteria (1 listed)
- male and female patients of all ages who underwent appendectomy of acute appendicitis in a single medical center between December 1, 2006, and December 31, 2016
Key exclusion criteria (5 listed)
- interval appendectomy,
- incidental appendectomy,
- appendectomy after failed antibiotic treatment for either acute appendicitis or peri-appendicular abscess
- patients with a non-inflamed appendix
- those in whom symptom onset before hospitalization was not noted.
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 |
|---|---|---|
| surgeryThis is a retrospective study that includes patients operated for suspicion of acute appendicitis | Other | – |
Primary outcome
proportion of complicated appendicitis
Time frame: finding during surgery/pathology
complicated appendicitis defined as either gangrenous appendicitis, perforation with abscess, perforation with local peritonitis, perforation with diffuse peritonitis
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 5 Jan 2021.
- Background: PubMed 31153584Ashkenazi I, Zeina AR, Olsha O. Early ultrasound in acute appendicitis avoids CT in most patients but delays surgery and increases complicated appendicitis if nondiagnostic - A retrospective study. Am J Surg. 2020 Apr;219(4):683-689. doi: 10.1016/j.amjsurg.2019.05.013. Epub 2019 May 25.
- Derived from this study: PubMed 35211772Ashkenazi I, Zeina AR, Olsha O. In-hospital delay of surgery increases the rate of complicated appendicitis in patients presenting with short duration of symptoms: a retrospective cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3879-3886. doi: 10.1007/s00068-022-01912-3. Epub 2022 Feb 24.
- Individual participant dataSharing planned: Undecided. De-identified data will be made available upon reasonable request
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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.
Itamar Ashkenazi, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Rambam Health Care Campus.
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 5 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 5 Jan 2021. 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?
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?
proportion of complicated appendicitis (time frame: finding during surgery/pathology). 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 NCT04689906, which also lists 2 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 5 Jan 2021.