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

Acute Appendicitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689906
• Other study ID #: HTVSPTAPP1
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

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