Patient Time and In-hospital Delay of Surgery Association With Complicated Appendicitis

Completed

• Conditions: Acute Appendicitis

• Registration Number: NCT04689906
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-12-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-08-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3137

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of complicated appendicitis	finding during surgery/pathology	complicated appendicitis defined as either gangrenous appendicitis, perforation with abscess, perforation with local peritonitis, perforation with diffuse peritonitis