Clinical trial NCT04689906: Patient Time and In-hospital Delay of Surgery Association With Complicated Appendicitis
Official title: In-hospital Delay of Surgery Increases the Rate of Complicated Appendicitis in Patients Presenting With Short Duration of Symptoms: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: Appendicitis
Ruptured Appendicitis
Appendectomy
Timing of Surgery
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Hillel Yaffe Medical Center
First posted: 2020-12-30
Enrollment: 3137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated in one medical center during one decade.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of complicated appendicitis
timeFrame: finding during surgery/pathology
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Itamar Ashkenazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ashkenazi I, Zeina AR, Olsha O. In-hospital delay of surgery increases the rate of complicated appendicitis in patients presenting with short duration of symptoms: a retrospective cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3879-3886. doi: 10.1007/s00068-022-01912-3. Epub 2022 Feb 24.