AppendicitisNCT03119740
Postoperative Complications After Appendectomy
An observational study of Appendicitis, run by Kepler University Hospital at 1 site in Austria.
Trial summary
The frequency of complications after appendectomy is about 9% . The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Appendicitis
- How many people
- 744 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2016to 30 Nov 2016
- 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 to 96 years
- All sexes
- Adult, Older adult
Study population: patients who had undergone open or laparoscopic appendectomy because of clinically suspected appendicitis between 1 January 2011 and 31 December 2015 at the department of general and visceral surgery, Kepler University Hospital in Linz, Austria
Who may be able to join
- clinically suspected appendicitis between 1 January 2011 and 31 December 2015
Who cannot join
- an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Clinic for General and Visceral Surgery, Kepler University Clinic Linz
Linz, Upper Austria, 4020
About this study
Official title: Clinical Value of Postoperative C-reactive Protein in the Detection of Complications After Open and Laparoscopic Appendectomy
The frequency of complications after appendectomy is about 9% . The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.
Read the detailed description
Background: Acute appendicitis is a common emergency in general surgery. The frequency of complications after appendectomy is about 9% [9]. The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.
Methods: This retrospective single-center cohort study comprised 744 patients who had undergone open or laparoscopic appendectomy for clinically suspected appendicitis between 1 January 2011 and 31 December 2015 at the department of general and visceral surgery, Kepler University Hospital in Linz, Austria. Demographic data, the surgical technique, postoperative complications, histopathological findings, postoperative white blood counts, and C-reactive protein levels were evaluated.
- Conditions
- Appendicitis
- 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 |
|---|---|---|
| open appendectomy | Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open appendectomy (AE) | |
| laparoscopic appendectomy | Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open laparoscopic appendectomy (LSK AE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
superficial wound infection
superficial wound infection in open and laparoscopic appendectomy
Measured: 4 weeks postoperative
Secondary outcomes (2)
intraabdominal abscess
intraabdominal abscess in open and laparoscopic appendectomy
Measured: 4 weeks postoperative
ileus
ileus in open and laparoscopic appendectomy
Measured: 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Aug 2016
- Primary completion30 Oct 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy
- Investigators
- Andreas Shamiyeh, MD, Study director, Clinic for General and Visceral Surgery, Kepler University Clinic Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119740
- Sponsor's protocol ID
- APPCO-017
- Status last verified
- Oct 2023
- First submitted
- 11 Apr 2017
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barkhausen S, Wullstein C, Gross E. [Laparoscopic versus conventional appendectomy--a comparison with reference to early postoperative complications]. Zentralbl Chir. 1998;123(7):858-62. German.
PubMed 9746989Izbicki JR, Knoefel WT, Wilker DK, Mandelkow HK, Muller K, Siebeck M, Schweiberer L. Accurate diagnosis of acute appendicitis: a retrospective and prospective analysis of 686 patients. Eur J Surg. 1992 Apr;158(4):227-31.
PubMed 1352137Kaya B, Sana B, Eris C, Karabulut K, Bat O, Kutanis R. The diagnostic value of D-dimer, procalcitonin and CRP in acute appendicitis. Int J Med Sci. 2012;9(10):909-15. doi: 10.7150/ijms.4733. Epub 2012 Nov 13.
PubMed 23236260
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Postoperative C-reactive Protein in the Detection of Complications After Open and Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT03119740
- Acronym / sponsor ID
- APPCO-017
- Conditions
- Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 19 Apr 2017 (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 frequency of complications after appendectomy is about 9% . The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.
Detailed description
Background: Acute appendicitis is a common emergency in general surgery. The frequency of complications after appendectomy is about 9% [9]. The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.
Methods: This retrospective single-center cohort study comprised 744 patients who had undergone open or laparoscopic appendectomy for clinically suspected appendicitis between 1 January 2011 and 31 December 2015 at the department of general and visceral surgery, Kepler University Hospital in Linz, Austria. Demographic data, the surgical technique, postoperative complications, histopathological findings, postoperative white blood counts, and C-reactive protein levels were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open appendectomy | – | –Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open appendectomy (AE) |
| laparoscopic appendectomy | – | –Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open laparoscopic appendectomy (LSK AE) |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who had undergone open or laparoscopic appendectomy because of clinically suspected appendicitis between 1 January 2011 and 31 December 2015 at the department of general and visceral surgery, Kepler University Hospital in Linz, Austria
Key inclusion criteria (1 listed)
- clinically suspected appendicitis between 1 January 2011 and 31 December 2015
Key exclusion criteria (1 listed)
- an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy
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
superficial wound infection
Time frame: 4 weeks postoperative
superficial wound infection in open and laparoscopic appendectomy
2 secondary outcomes
intraabdominal abscess
Time frame: 4 weeks postoperative
ileus
Time frame: 4 weeks postoperative
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 Oct 2023.
- Background: PubMed 9746989Barkhausen S, Wullstein C, Gross E. [Laparoscopic versus conventional appendectomy--a comparison with reference to early postoperative complications]. Zentralbl Chir. 1998;123(7):858-62. German.
- Background: PubMed 1352137Izbicki JR, Knoefel WT, Wilker DK, Mandelkow HK, Muller K, Siebeck M, Schweiberer L. Accurate diagnosis of acute appendicitis: a retrospective and prospective analysis of 686 patients. Eur J Surg. 1992 Apr;158(4):227-31.
- Background: PubMed 23236260Kaya B, Sana B, Eris C, Karabulut K, Bat O, Kutanis R. The diagnostic value of D-dimer, procalcitonin and CRP in acute appendicitis. Int J Med Sci. 2012;9(10):909-15. doi: 10.7150/ijms.4733. Epub 2012 Nov 13.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Shamiyeh, MD study director
Clinic for General and Visceral Surgery, Kepler University Clinic Linz
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 Appendicitis, run by Kepler University Hospital at 1 site in Austria.
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: finished, as of the sponsor's last update on 5 Oct 2023. 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 Austria. 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?
superficial wound infection (time frame: 4 weeks postoperative). 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 NCT03119740, which also lists 3 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 Oct 2023.