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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04689906
Other study ID # HTVSPTAPP1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2006
Est. completion date August 1, 2017

Study information

Verified date December 2020
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective observational study with its main aim of evaluating possible factors associated with complicated appendicitis. Current literature supports time from symptom onset until registration as the main and maybe only determinant of the outcome if patients are operated on within 24 hours. We wish to evaluate whether this is true in all patients, or there are subgroups in which time from registration to operation is associated with complicated appendicitis.


Description:

The data to be analyzed is that of patients operated on acutely for suspected appendicitis within 10 years in one medical center. Patients undergoing interval or incidental appendectomies will not be included. The endpoint to be evaluated is complicated appendicitis (gangrenous, abscess, perforated). The independent variables will include mainly sex, age, patient time (time from symptom onset to registration), hospital time (time from registration to operation), and missed diagnosis.


Recruitment information / eligibility

Status Completed
Enrollment 3137
Est. completion date August 1, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - male and female patients of all ages who underwent appendectomy of acute appendicitis in a single medical center between December 1, 2006, and December 31, 2016 Exclusion Criteria: - interval appendectomy, - incidental appendectomy, - appendectomy after failed antibiotic treatment for either acute appendicitis or peri-appendicular abscess - patients with a non-inflamed appendix - those in whom symptom onset before hospitalization was not noted.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
surgery
This is a retrospective study that includes patients operated for suspicion of acute appendicitis

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Rambam Health Care Campus Hillel Yaffe Medical Center

References & Publications (1)

Ashkenazi I, Zeina AR, Olsha O. Early ultrasound in acute appendicitis avoids CT in most patients but delays surgery and increases complicated appendicitis if nondiagnostic - A retrospective study. Am J Surg. 2020 Apr;219(4):683-689. doi: 10.1016/j.amjsurg.2019.05.013. Epub 2019 May 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of complicated appendicitis complicated appendicitis defined as either gangrenous appendicitis, perforation with abscess, perforation with local peritonitis, perforation with diffuse peritonitis finding during surgery/pathology
See also
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