Management of Acute Appendicitis at District General Hospital

Sponsor
Princess Alexandra Hospital NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04707339
Collaborator
(none)
200
1
12
16.6

Study Details

Study Description

Brief Summary

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?

Condition or Disease Intervention/Treatment Phase
  • Procedure: Appendicectomy

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Management of Acute Appendicitis at District General Hospital
Actual Study Start Date :
Jan 30, 2020
Actual Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Jan 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Negative Appendicectomy Rate [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.

  2. Outcomes of Conservative vs Operative Management [8 months]

    The outcomes of both conservatively and operatively managed patients will be assessed to define the best management approach.

  3. Increased Open Appendicectomy Rate [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?

  4. Surgical site infection in patients on antibiotics [8 months]

    The rate of incidence of superficial and deep wound infection will be calculated to define the applicability of use of Antibiotics

Secondary Outcome Measures

  1. Length of Stay [8 months]

    The number of days of postoperative admission in hospital will be assessed while comparing the type of surgery and co-morbidities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Princess Alexandra Hospital NHS Trust Harlow Essex United Kingdom CM20 1EL

Sponsors and Collaborators

  • Princess Alexandra Hospital NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Naveed Kirmani, Principal Investigator, Princess Alexandra Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT04707339
Other Study ID Numbers:
  • 3810
First Posted:
Jan 13, 2021
Last Update Posted:
Jan 14, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Naveed Kirmani, Principal Investigator, Princess Alexandra Hospital NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2021