NCT04689906

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,137

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

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

December 1, 2006

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

10.1 years

First QC Date

December 28, 2020

Last Update Submit

December 30, 2020

Conditions

Keywords

AppendicitisRuptured AppendicitisAppendectomyTiming of Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

surgeryOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated in one medical center during one decade.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31153584BACKGROUND
  • 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.

MeSH Terms

Conditions

Appendicitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Itamar Ashkenazi, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 30, 2020

Study Start

December 1, 2006

Primary Completion

December 31, 2016

Study Completion

August 1, 2017

Last Updated

January 5, 2021

Record last verified: 2020-12