Reduction of Negative Appendectomy RateDIALAPPNCT02627781
Diagnostic Algorithm for Appendizitis (DIALAPP)
An observational study of Reduction of Negative Appendectomy Rate, run by Goethe University at 1 site in Germany.
Trial summary
The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to negative appendectomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Negative Appendectomy Rate
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to May 2018
- How long will I take part?
- 6 Months
- 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 admitted to our University department with suspected appendicitis and/or lower right abdominal pain.
Who may be able to join
- complete evaluation, examination and diagnostic pathways of the patients with suspected appendicitis in our University Hospital
Who cannot join
- appendectomy during other operations
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Goethe University
Frankfurt, 60590
Juliane Liese, MD, +4963015251, juliane.liese@kgu.de
Alexander Reinisch, MD, +4963016502, alexander.reinisch@kgu.de
About this study
Official title: Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis
The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to negative appendectomies. The aim of the present observation study is to evaluate a diagnostic and therapeutic algorithm for suspected acute appendicitis.
The investigators believe that this diagnostic algorithm helps to simultaneously avoid unnecessary operations, costs and radiation exposure.
Read the detailed description
This prospective observation study will be performed in the university hospital Frankfurt with a 24-h emergency service, with surgery and radiology readily available. The data will be compiled on patients older than 18 years who will be admitted to the emergency unit with suspected appendicitis.
During the study period, the clinical workflow is standardized. In all cases a resident of surgery and/or consultant surgeon clinically evaluate and perform an ultrasound scan on all patients with suspected appendicitis. With the use of clinical and laboratory results the physician (surgeon) will calculate the Alvarado Score and depending on the result the next diagnostic steps or the treatment will be chosen. Additionally, the department of gynecology of the university hospital routinely evaluate all women of childbearing age. Upon other terms following variables will be collected: age, gender, white blood cells (WBC), C-reactive protein (CRP), Alvarado Score, visuell pain scale, CT scan results, pathologic findings, time between admission and operation, operation procedure, treatment and diagnosis of patients without operation, length of hospital stay, and 30-day complication rate. Furthermore, there will be a follow-up of all patients (with and without operation) after 30 days and 6 months.
The investigators assume that the use of a diagnostic and therapeutic algorithm reduces unnecessary negative appendectomies and optimizes the duration of the hospital stay and the costs.
- Conditions
- Reduction of Negative Appendectomy Rate
- Keywords
- acute appendicitis, Alvarado Score, negative appendectomy, right abdominal pain
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| suspected appendicitis | This group includes all patients with suspected appendicitis, who are admitted to our University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the negative appendectomy rate
In this part of the study, the negative appendectomy rate will be determined. A negative appendectomy is characterized by normal findings in the pathological examination and therefore constitutes a medically unnecessary appendectomy.
Measured: 6 months
Secondary outcomes (3)
The influence of computed tomography for the diagnosis of acute appendicitis
In this part of the study the investigators evaluate the careful and cost-effective integration of computed tomography in the clinical pathway.
Measured: 30 days
Incidence of readmission to hospital
In this part of the study the readmission rate to hospital will be evaluated because of postoperative complications, infections and continuous abdominal pain will be included.
Measured: 6 months
Evaluation of postoperative complications
In all patients, who received an appendectomy the postoperative complication rate will be recorded. In statistical analysis factors, which are associated with complications will be analyzed.
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 posted11 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionMay 2018 (estimated)
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 Reduction of Negative Appendectomy RateStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Juliane Liese, Goethe University
- Investigators
- Juliane Liese, MD, Principal investigator, General and Visceral Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627781
- Sponsor's protocol ID
- 268/15
- Acronym
- DIALAPP
- Status last verified
- Aug 2016
- First submitted
- 4 Dec 2015
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malkomes P, Edmaier F, Liese J, Reinisch-Liese A, El Youzouri H, Schreckenbach T, Bucher AM, Bechstein WO, Schnitzbauer AA. DIALAPP: a prospective validation of a new diagnostic algorithm for acute appendicitis. Langenbecks Arch Surg. 2021 Feb;406(1):141-152. doi: 10.1007/s00423-020-02022-7. Epub 2020 Nov 19.
PubMed 33210209
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis
- ClinicalTrials.gov ID
- NCT02627781
- Acronym / sponsor ID
- DIALAPP / 268/15
- Conditions
- Reduction of Negative Appendectomy Rate
- Keywords
- acute appendicitis, Alvarado Score, negative appendectomy, right abdominal pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 11 Dec 2015 (estimated)
- 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 diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to negative appendectomies. The aim of the present observation study is to evaluate a diagnostic and therapeutic algorithm for suspected acute appendicitis.
The investigators believe that this diagnostic algorithm helps to simultaneously avoid unnecessary operations, costs and radiation exposure.
Detailed description
This prospective observation study will be performed in the university hospital Frankfurt with a 24-h emergency service, with surgery and radiology readily available. The data will be compiled on patients older than 18 years who will be admitted to the emergency unit with suspected appendicitis.
During the study period, the clinical workflow is standardized. In all cases a resident of surgery and/or consultant surgeon clinically evaluate and perform an ultrasound scan on all patients with suspected appendicitis. With the use of clinical and laboratory results the physician (surgeon) will calculate the Alvarado Score and depending on the result the next diagnostic steps or the treatment will be chosen. Additionally, the department of gynecology of the university hospital routinely evaluate all women of childbearing age. Upon other terms following variables will be collected: age, gender, white blood cells (WBC), C-reactive protein (CRP), Alvarado Score, visuell pain scale, CT scan results, pathologic findings, time between admission and operation, operation procedure, treatment and diagnosis of patients without operation, length of hospital stay, and 30-day complication rate. Furthermore, there will be a follow-up of all patients (with and without operation) after 30 days and 6 months.
The investigators assume that the use of a diagnostic and therapeutic algorithm reduces unnecessary negative appendectomies and optimizes the duration of the hospital stay and the costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected appendicitis | – | –This group includes all patients with suspected appendicitis, who are admitted to our University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our University department with suspected appendicitis and/or lower right abdominal pain.
Key inclusion criteria (1 listed)
- complete evaluation, examination and diagnostic pathways of the patients with suspected appendicitis in our University Hospital
Key exclusion criteria (1 listed)
- appendectomy during other operations
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
Evaluation of the negative appendectomy rate
Time frame: 6 months
In this part of the study, the negative appendectomy rate will be determined. A negative appendectomy is characterized by normal findings in the pathological examination and therefore constitutes a medically unnecessary appendectomy.
3 secondary outcomes
The influence of computed tomography for the diagnosis of acute appendicitis
Time frame: 30 days
Incidence of readmission to hospital
Time frame: 6 months
Evaluation of postoperative complications
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 1 Sep 2016.
- Derived from this study: PubMed 33210209Malkomes P, Edmaier F, Liese J, Reinisch-Liese A, El Youzouri H, Schreckenbach T, Bucher AM, Bechstein WO, Schnitzbauer AA. DIALAPP: a prospective validation of a new diagnostic algorithm for acute appendicitis. Langenbecks Arch Surg. 2021 Feb;406(1):141-152. doi: 10.1007/s00423-020-02022-7. Epub 2020 Nov 19.
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.
Juliane Liese, MD principal investigator
General and Visceral Surgery
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 Reduction of Negative Appendectomy Rate, run by Goethe University 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 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 1 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliane Liese, MD (+496963015251, juliane.liese@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the negative appendectomy rate (time frame: 6 months). 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 NCT02627781, 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 1 Sep 2016.