NCT04615728

Brief Summary

During the Covid-19 pandemic, non-operative management for acute appendicitis (AA) was implemented in the UK. The aim of this study was to determine the efficacy and outcomes of conservative versus surgical management of AA during the pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 2, 2020

Last Update Submit

November 2, 2020

Conditions

Keywords

acute appendicitis; COVID-19; conservative management; antibiotic therapy; laparoscopic appendicectomy; open surgery

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Death secondary to acute appendicitis

    within 90 days of a patient's initial presentation

  • Failure of primary proposed treatment

    failure of conservative management and need to undergo surgery

    within 90 days of a patient's initial presentation

Secondary Outcomes (4)

  • length of stay

    within 90 days of a patient's initial presentation

  • Re-attendance

    within 90 days of a patient's initial presentation

  • Imaging

    within 90 days of a patient's initial presentation

  • Intra-operative findings during surgery

    within 90 days of a patient's initial presentation

Study Arms (2)

pre-COVID cohort

Patients recruited from 1st November 2019 to 9th March 2020

Procedure: laparoscopic or open appendicectomy

COVID cohort

Patients recruited from 10th March 2020 to 5th July 2020

Procedure: laparoscopic or open appendicectomy

Interventions

Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection

Also known as: conservative antibiotic therapy
COVID cohortpre-COVID cohort

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients included in this study were all adults (≥16 years) with a diagnosis of acute appendicitis made clinically and/or radiologically in our hospital. Patients presented sequentially to the emergency department, and subsequently were referred to the emergency surgical service for further management.

You may qualify if:

  • Patients aged 16 years old and above
  • Confirmed diagnosis of acute appendicitis

You may not qualify if:

  • Patients aged less than 16 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's University Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

AppendicitisCOVID-19

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 4, 2020

Study Start

November 1, 2019

Primary Completion

July 5, 2020

Study Completion

October 6, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

As individual participant data contain private confidential data, this data will not be shared or made available publicly however the primary would be to answer or clarify any relevant queries.

Locations