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Postoperative Complications After Appendectomy

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ClinicalTrials.gov Identifier: NCT03119740
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy

Study Description
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Brief 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. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.

Condition or disease
Appendicitis

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
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Study Type : Observational
Actual Enrollment : 744 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Value of Postoperative C-reactive Protein in the Detection of Complications After Open and Laparoscopic Appendectomy
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : November 30, 2016

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Groups and Cohorts
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Group/Cohort
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)


Outcome Measures
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Primary Outcome Measures :
  1. superficial wound infection [ Time Frame: 4 weeks postoperative ]
    superficial wound infection in open and laparoscopic appendectomy


Secondary Outcome Measures :
  1. intraabdominal abscess [ Time Frame: 4 weeks postoperative ]
    intraabdominal abscess in open and laparoscopic appendectomy

  2. ileus [ Time Frame: 4 weeks postoperative ]
    ileus in open and laparoscopic appendectomy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 96 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119740


Locations
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Austria
Clinic for General and Visceral Surgery, Kepler University Clinic Linz
Linz, Upper Austria, Austria, 4020
Sponsors and Collaborators
Ludwig Boltzmann Institute for Operative Laparoscopy
Investigators
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Study Director: Andreas Shamiyeh, MD Clinic for General and Visceral Surgery, Kepler University Clinic Linz
More Information
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Publications:

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Responsible Party: Klugsberger Bettina, MD, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier: NCT03119740    
Other Study ID Numbers: APPCO-017
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases