- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03119740
Postoperative Complications After Appendectomy
Clinical Value of Postoperative C-reactive Protein in the Detection of Complications After Open and Laparoscopic Appendectomy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Clinic for General and Visceral Surgery, Kepler University Clinic Linz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- clinically suspected appendicitis between 1 January 2011 and 31 December 2015
Exclusion Criteria:
- an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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open appendectomy
Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open appendectomy (AE)
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laparoscopic appendectomy
Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open laparoscopic appendectomy (LSK AE)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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superficial wound infection
Time Frame: 4 weeks postoperative
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superficial wound infection in open and laparoscopic appendectomy
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4 weeks postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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intraabdominal abscess
Time Frame: 4 weeks postoperative
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intraabdominal abscess in open and laparoscopic appendectomy
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4 weeks postoperative
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ileus
Time Frame: 4 weeks postoperative
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ileus in open and laparoscopic appendectomy
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4 weeks postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andreas Shamiyeh, MD, Clinic for General and Visceral Surgery, Kepler University Clinic Linz
Publications and helpful links
General 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.
- Izbicki 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.
- Kaya 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APPCO-017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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