Management of Acute Appendicitis at District General Hospital

January 12, 2021 updated by: Naveed Kirmani, Princess Alexandra Hospital NHS Trust

The Investigators aim to assess;

  1. whether the changes in managing patients during COVID has reduced the negative appendicectomy rate?
  2. compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis?
  3. Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes?
  4. Whether the incidence of complicated appendicitis has increased?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As acute appendicitis is the most commonly managed emergency presentation for surgeons, the investigators aim to assess whether the changes in managing patients during COVID has reduced the negative appendicectomy rate, to compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis? to assess whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? to assess whether the incidence of complicated appendicitis has increased? This will be a single centre retrospective observational study. All the patients presenting in A&E department with a diagnosis of acute appendicitis to be included. the only exclusion criteria are the age of participants for less than 5 years. The data will be analysed and calculated using SPSS version 23.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

All patients with a diagnosis of Acute Appendicitis will be included

Description

Inclusion Criteria:

  • All participants reporting in accident and emergency with a diagnosis of acute appendicitis irrespective of age above 5 years, gender and morbidities (this group for conservative management)

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Appendicitis pre-COVID management
Audit of Acute appendicitis management in 2017-18
Procedure: Appendicectomy
Laparoscopic or Open Appendicectomy
Acute Appendicitis during COVID management
Audit of Acute appendicitis management in 2020
Procedure: Appendicectomy
Laparoscopic or Open Appendicectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Appendicectomy Rate
Time Frame: 8 months
Negative appendicectomy rate will be calculated to define the benefits of increasing the preoperative scanning in the form of ultrasound, CT scan or both.
8 months
Outcomes of Conservative vs Operative Management
Time Frame: 8 months
The outcomes of both conservatively and operatively managed patients will be assessed to define the best management approach.
8 months
Increased Open Appendicectomy Rate
Time Frame: 8 months
The rate of laparoscopic to open and open appendicectomy rate will be calculated to understand if the surgical practice has been changed during COVID-19 pandemic?
8 months
Surgical site infection in patients on antibiotics
Time Frame: 8 months
The rate of incidence of superficial and deep wound infection will be calculated to define the applicability of use of Antibiotics
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: 8 months
The number of days of postoperative admission in hospital will be assessed while comparing the type of surgery and co-morbidities.
8 months

Collaborators and Investigators

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

Sponsor

Princess Alexandra Hospital NHS Trust

Investigators

  • Principal Investigator: Naveed Kirmani, FRCS, The Princess Alexandra Hospital NHS Trust

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)

January 30, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Anticipated)

January 30, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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