Perforated AppendicitisNCT04472052
Frequency of Perforated Appendicitis in Times of COVID-19
An observational study of Perforated Appendicitis and Covid19, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Perforated Appendicitis, Covid19
- What is being tested?
- appendectomy
- How many people
- 143 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2020to 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with acute appendicitis
Who may be able to join
- patients with acute appendicitis older than 16 years
- appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and 2020
Who cannot join
- patients with acute appendicitis younger than 16 years
- appendectomy not in the named time frames
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Perforated Appendicitis in Times of Corona Crisis
Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Patients usually leave the hospital two days after surgery.
In times of corona crisis, patients are unsure to visit the hospital because of fear of infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an indicator for fear-related delay of going to the hospital.
Methods: Investigators performed a retrospective analysis on the incidence of perforated appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020 to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures, complications and the length of hospital stay were considered.
Read the detailed description
The local ethics committee of the University Hospital of Tübingen, Germany, approved this study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study. Investigators analysed the frequency of perforated appendicitis in the periods indicated. Informed consent was obtained from all individual participants. Patient's records as well as database were analyzed for therapy specific items.
Definition Perforation: Perforated appendicitis was defined as described perforation in the surgical or pathological results.
Delay between onset of symptoms and first presentation at the hospital: Patient's records were proved for self-declaration about the start of symptoms
- Conditions
- Perforated Appendicitis, Covid19
- Being tested
- appendectomy
- Keywords
- acute appendicitis, COVID-19
- Medical subject headings
- Appendicitis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendectomyOther
Surgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Appendectomy | Patients who required appendectomy for suspected acute appendicitis Receives: Other: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of perforated appendicitis
Measured: 10 weeks from 16th of March to 31th of May
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start16 Mar 2020
- 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 Perforated AppendicitisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472052
- Sponsor's protocol ID
- AZ: 324/2020BO2
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers could send a request for the IPD to the investigators and will receive the required data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Perforated Appendicitis in Times of Corona Crisis
- ClinicalTrials.gov ID
- NCT04472052
- Acronym / sponsor ID
- AZ: 324/2020BO2
- Conditions
- Perforated Appendicitis, Covid19
- Keywords
- acute appendicitis, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 15 Jul 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.
Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Patients usually leave the hospital two days after surgery.
In times of corona crisis, patients are unsure to visit the hospital because of fear of infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an indicator for fear-related delay of going to the hospital.
Methods: Investigators performed a retrospective analysis on the incidence of perforated appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020 to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures, complications and the length of hospital stay were considered.
Detailed description
The local ethics committee of the University Hospital of Tübingen, Germany, approved this study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study. Investigators analysed the frequency of perforated appendicitis in the periods indicated. Informed consent was obtained from all individual participants. Patient's records as well as database were analyzed for therapy specific items.
Definition Perforation: Perforated appendicitis was defined as described perforation in the surgical or pathological results.
Delay between onset of symptoms and first presentation at the hospital: Patient's records were proved for self-declaration about the start of symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Appendectomy | – | Other: appendectomyPatients who required appendectomy for suspected acute appendicitis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with acute appendicitis
Key inclusion criteria (2 listed)
- patients with acute appendicitis older than 16 years
- appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and 2020
Key exclusion criteria (2 listed)
- patients with acute appendicitis younger than 16 years
- appendectomy not in the named time frames
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 |
|---|---|---|
| appendectomySurgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery. | Other | Appendectomy |
Primary outcome
rate of perforated appendicitis
Time frame: 10 weeks from 16th of March to 31th of May
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 15 Jul 2020.
- Individual participant dataSharing planned: No. Researchers could send a request for the IPD to the investigators and will receive the required data.
Related trials for Perforated Appendicitis
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated 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.
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 Perforated Appendicitis and Covid19, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 2 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 15 Jul 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 Germany. 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?
rate of perforated appendicitis (time frame: 10 weeks from 16th of March to 31th of May). 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 15 Jul 2020.