Acute AppendicitisTreatAppNCT06558760
Changes in the Treatment of Acute Appendicitis
An observational study of Acute Appendicitis, run by Medizinische Hochschule Brandenburg Theodor Fontane.
Trial summary
The purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- How many people
- 31,988 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute appendicitis in 68 hospitals in Germany collected by routine data between 2010 and 2022.
Who may be able to join
- Acute Appendicitis
Who cannot join
- Age under 18 years
- No appendectomy performed
About this study
Official title: Continuous Decline in Open Appendectomies to 0.9% and Conversions to 2%
The purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022.
Read the detailed description
This retrospective observational study analyzed routine data provided by the CLINOTEL Hospital Association Germany, covering the years 2010 to 2022. The data was derived from anonymized billing data according to the German Diagnosis-Related Groups (DRG) system for inpatient hospital treatments.
The study focused on the use of different surgical techniques for appendectomy over time, the in-hospital mortality rates and postoperative complications associated with the performed kind of appendectomy.
Patients over 18 years with an acute appendicitis were included by collecting following data: patient demographic, comorbidity, performed operation, postoperative complications, admission to Intensive Care Unit, length of stay, and in-hospital-mortality. Cases without an appendectomy, with nonspecific appendectomy and those, who underwent appendectomy as part of another surgical procedure, were excluded. Furthermore, all cases with multiple appendectomy codes were removed from the sample. Ultimately, 31988 patients were included in the study.
- Conditions
- Acute Appendicitis
- Keywords
- Acute Appendicitis, Type of appendectomy
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in surgical techniques over time
Development of the use of surgical techniques (open, laparoscopic or conversion from open to laparoscopic)
Measured: 2010-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jan 2010
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 31,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Collaborators
- CLINOTEL Hospital Association Germany
- Responsible party
- Principal investigator, Habil Claus Schildberg, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558760
- Sponsor's protocol ID
- TreatApp
- Acronym
- TreatApp
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not available for data sharing.
Publications
Schildberg C, Weber U, Konig V, Linnartz M, Heisler S, Hafkesbrink J, Fricke M, Mantke R. Laparoscopic appendectomy as the gold standard: What role remains for open surgery, conversion, and disease severity? : An analysis of 32,000 cases with appendicitis in Germany. World J Emerg Surg. 2025 Jun 18;20(1):53. doi: 10.1186/s13017-025-00626-2.
PubMed 40533760
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Decline in Open Appendectomies to 0.9% and Conversions to 2%
- ClinicalTrials.gov ID
- NCT06558760
- Acronym / sponsor ID
- TreatApp / TreatApp
- Conditions
- Acute Appendicitis
- Keywords
- Acute Appendicitis, Type of appendectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,988 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Collaborators
- CLINOTEL Hospital Association Germany
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Aug 2024 (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 purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022.
Detailed description
This retrospective observational study analyzed routine data provided by the CLINOTEL Hospital Association Germany, covering the years 2010 to 2022. The data was derived from anonymized billing data according to the German Diagnosis-Related Groups (DRG) system for inpatient hospital treatments.
The study focused on the use of different surgical techniques for appendectomy over time, the in-hospital mortality rates and postoperative complications associated with the performed kind of appendectomy.
Patients over 18 years with an acute appendicitis were included by collecting following data: patient demographic, comorbidity, performed operation, postoperative complications, admission to Intensive Care Unit, length of stay, and in-hospital-mortality. Cases without an appendectomy, with nonspecific appendectomy and those, who underwent appendectomy as part of another surgical procedure, were excluded. Furthermore, all cases with multiple appendectomy codes were removed from the sample. Ultimately, 31988 patients were included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute appendicitis in 68 hospitals in Germany collected by routine data between 2010 and 2022.
Key inclusion criteria (1 listed)
- Acute Appendicitis
Key exclusion criteria (2 listed)
- Age under 18 years
- No appendectomy performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in surgical techniques over time
Time frame: 2010-2022
Development of the use of surgical techniques (open, laparoscopic or conversion from open to laparoscopic)
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 19 Aug 2024.
- Derived from this study: PubMed 40533760Schildberg C, Weber U, Konig V, Linnartz M, Heisler S, Hafkesbrink J, Fricke M, Mantke R. Laparoscopic appendectomy as the gold standard: What role remains for open surgery, conversion, and disease severity? : An analysis of 32,000 cases with appendicitis in Germany. World J Emerg Surg. 2025 Jun 18;20(1):53. doi: 10.1186/s13017-025-00626-2.
- Individual participant dataSharing planned: No. Individual participant data is not available for data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Medizinische Hochschule Brandenburg Theodor Fontane.
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 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 19 Aug 2024. 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?
Changes in surgical techniques over time (time frame: 2010-2022). 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 NCT06558760, which also lists 1 linked publication.
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 19 Aug 2024.