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

December 30, 2020 updated by: Itamar Ashkenazi MD, Rambam Health Care Campus

In-hospital Delay of Surgery Increases the Rate of Complicated Appendicitis in Patients Presenting With Short Duration of Symptoms: a Retrospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated in one medical center during one decade.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of complicated appendicitis
Time Frame: finding during surgery/pathology
complicated appendicitis defined as either gangrenous appendicitis, perforation with abscess, perforation with local peritonitis, perforation with diffuse peritonitis
finding during surgery/pathology

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Itamar Ashkenazi, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2006

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTVSPTAPP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

De-identified data will be made available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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