NCT03119740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

April 11, 2017

Last Update Submit

October 3, 2023

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • superficial wound infection

    superficial wound infection in open and laparoscopic appendectomy

    4 weeks postoperative

Secondary Outcomes (2)

  • intraabdominal abscess

    4 weeks postoperative

  • ileus

    4 weeks postoperative

Study Arms (2)

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)

Eligibility Criteria

Age18 Years - 96 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • clinically suspected appendicitis between 1 January 2011 and 31 December 2015

You may not qualify if:

  • an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for General and Visceral Surgery, Kepler University Clinic Linz

Linz, Upper Austria, 4020, Austria

Location

Related Publications (3)

  • 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.

    PMID: 9746989BACKGROUND

  • 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.

    PMID: 1352137BACKGROUND

  • 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.

    PMID: 23236260BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Andreas Shamiyeh, MD

    Clinic for General and Visceral Surgery, Kepler University Clinic Linz

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 19, 2017

Study Start

August 1, 2016

Primary Completion

October 30, 2016

Study Completion

November 30, 2016

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

AU(1)